Category: Pipeline (investigational)

In short: The next FDA decisions on weight-loss medicines are close. CagriSema, a weekly combination injection from Novo Nordisk, has been under FDA review since December 2025, with a decision the company expects in the fourth quarter of 2026, so it may land late this year or slip into 2027. Lilly plans to apply for retatrutide in early 2027, and several other drugs finish their main trials during 2027 but will not reach a decision until later. None of these is approved today. Checked on October 7, 2026.

This page is our yearly look ahead. It lists the weight-loss treatments with an FDA decision pending or likely in the next 12 to 18 months, what the trials showed, and the dated changes to price and coverage already set for 2027. For every candidate in development, including early-stage drugs, see our emerging medications tracker. For what you can use today, see our comparison of every FDA-approved weight-loss medication. This is general education, not advice about any treatment.

How an FDA decision date is set

It helps to know the clock before reading any “coming soon” headline. For a brand-new medicine, the FDA first takes up to 60 days to decide whether the application is complete enough to review. Under the user-fee goals the agency has agreed with industry for 2023 to 2027, it then aims to act on a standard application within 10 months and a priority one within 6 months of that 60-day filing date. That is why a drug submitted in a given month usually gets its decision about a year later, or about eight months later with priority review.

There is now a faster lane. Under the Commissioner’s National Priority Voucher program, launched in 2025, the FDA’s target is a decision within about two months. The first new medicine approved this way was Foundayo (orforglipron), the daily weight-loss pill, on April 1, 2026: 50 days after filing and 294 days ahead of its original goal date of January 20, 2027. A voucher can therefore move a decision forward by most of a year, which makes any forecast less certain.

The status board

The table lists candidates in the order their FDA decision could come, based on public information. It is not a ranking, and later rows are further from a decision.

Treatment (company)	What it is	Stage on Oct 7, 2026	FDA application	Earliest decision
CagriSema (Novo Nordisk)	Weekly injection: amylin analogue cagrilintide plus semaglutide	Phase 3 complete (REDEFINE 1, 2, 4, 5)	Filed December 2025 (reported)	Q4 2026, company expectation; could move into 2027
Foundayo for type 2 diabetes (Lilly)	Daily pill already approved for weight management; new diabetes use	Phase 3 complete (ACHIEVE program)	Planned by end of Q2 2026 under a priority voucher (reported); no decision found	Not announced
Retatrutide (Lilly)	Weekly injection acting on GIP, GLP-1 and glucagon receptors	Phase 3: four trials reported; head-to-head vs tirzepatide due Nov 2026 (registry estimate)	Planned Q1 2027 (reported)	Late 2027 or 2028 on a standard clock; sooner only with a voucher
Survodutide (Boehringer Ingelheim)	Weekly injection acting on glucagon and GLP-1 receptors	Phase 3: SYNCHRONIZE-1 and -2 reported; heart-safety trial completed June 2026	None announced	Not before late 2027
MariTide (Amgen)	Monthly or less frequent injection (antibody-peptide)	Phase 3: MARITIME-1 (3,853 adults) primary completion Jan 2027 (registry estimate)	None announced	2028 or later
VK2735 (Viking)	Weekly injection acting on GIP and GLP-1 receptors	Phase 3: VANQUISH 1 primary completion July 2027 (registry estimate)	None announced	2028 or later
Eloralintide (Lilly), zenagamtide (Novo Nordisk)	Amylin-based injections; zenagamtide was previously called amycretin	Phase 3 recruiting; main trials list completion 2028-2029	None	Not before 2028

CagriSema: the decision closest to happening

CagriSema pairs semaglutide, the ingredient in Wegovy, with cagrilintide, a long-acting version of amylin, a hormone that helps signal fullness. In REDEFINE 1, published in 2025, 3,417 adults without diabetes lost 20.4% of their body weight on average over 68 weeks, compared with 3.0% on placebo, counting everyone who started. People with type 2 diabetes lost 13.7% vs 3.4% in REDEFINE 2. In an open-label head-to-head trial against tirzepatide, REDEFINE 4, Novo reported that CagriSema did not meet its goal of showing it was at least as effective (20.2% vs 23.6% at 84 weeks, treatment-regimen estimand). Digestive side effects were common, affecting 79.6% vs 39.9% on placebo in REDEFINE 1, mostly mild to moderate and temporary.

Novo filed with the FDA in December 2025 and, in its September 30, 2026 announcement, still said it expects a decision in the fourth quarter of 2026. We found no FDA decision as of October 7. If approved, the label would set who it is for and its warnings; price and coverage would follow. Our CagriSema explainer has every trial in detail.

Retatrutide: the application to watch in 2027

Retatrutide produced the largest average weight losses reported so far in a medicine trial. In TRIUMPH-1, published in the New England Journal of Medicine in September 2026, 2,339 adults with obesity lost 25.0% on the highest dose over 80 weeks vs 3.9% on placebo, counting everyone randomized. Lilly says it plans to submit retatrutide to the FDA in the first quarter of 2027. On a standard clock, that points to a decision in late 2027 or early 2028; Lilly has not said whether it will use a priority voucher. A head-to-head trial against tirzepatide, TRIUMPH-5, lists its primary completion for November 2026, so those results could arrive before the application. Our retatrutide results explainer covers the side effects, including the skin-sensation effect called dysesthesia.

• Investigational drug, highest dose
• Placebo

CagriSema, REDEFINE 1, 68 wk20.4%3%

Retatrutide, TRIUMPH-1, 80 wk25%3.9%

Survodutide, SYNCHRONIZE-1, 76 wk16.6%3.2%

Weight loss in each candidate's main Phase 3 trial vs placebo

Item	Investigational drug, highest dose	Placebo
CagriSema, REDEFINE 1, 68 wk	20.4%	3%
Retatrutide, TRIUMPH-1, 80 wk	25%	3.9%
Survodutide, SYNCHRONIZE-1, 76 wk	16.6%	3.2%

INVESTIGATIONAL. Different trials, people and lengths: not a ranking. CagriSema and retatrutide figures count everyone randomized; the survodutide figure is company-reported and assumes everyone stayed on treatment (efficacy estimand), which gives higher numbers.

Source: Garvey WT et al., NEJM 2025 (REDEFINE 1); Jastreboff AM et al., NEJM 2026 (TRIUMPH-1); Boehringer Ingelheim release, April 28, 2026 (SYNCHRONIZE-1) (checked on October 7, 2026)

Read those bars with care. They come from separate trials with different lengths, and the survodutide number is measured in the more generous way. Our guide on how to read a weight-loss study headline explains why the same trial can produce two different percentages. For context, people in the trials behind today’s leading approved medicines lost 14.9% with semaglutide 2.4 mg over 68 weeks (STEP 1) and 20.9% with tirzepatide 15 mg over 72 weeks (SURMOUNT-1).

Further out: survodutide, MariTide, VK2735 and amylin drugs

Survodutide from Boehringer Ingelheim works on glucagon and GLP-1 receptors. On April 28, 2026, the company reported that in SYNCHRONIZE-1, 725 adults without diabetes lost up to 16.6% vs 3.2% on placebo over 76 weeks (efficacy estimand, company-reported), and 85.1% lost at least 5%. In SYNCHRONIZE-2, published in 2026, 752 adults with type 2 diabetes lost 8.2% and 9.8% on the two doses vs 3.9% on placebo, counting everyone randomized. Its heart-safety trial, with 5,531 participants, lists completion in June 2026. The company has not announced an FDA filing, so a decision before late 2027 is unlikely.

MariTide (maridebart cafraglutide) from Amgen is designed to be injected once a month or less often. In its Phase 2 trial, published in 2025, adults with obesity lost 12.3% to 16.2% at 52 weeks vs 2.5% on placebo. Its main Phase 3 trial, MARITIME-1, has enrolled 3,853 adults and lists primary completion in January 2027, so results could be one of the big news items of 2027, but a decision would come later. VK2735 from Viking, a weekly GIP and GLP-1 injection with an oral version in earlier testing, has a 4,500-person Phase 3 trial listed to complete in July 2027.

Several amylin-based medicines are in Phase 3: eloralintide from Lilly (ENLIGHTEN-1, completion listed March 2028), zenagamtide from Novo Nordisk (the AMAZE program, previously called amycretin) and petrelintide (Zealand with Roche). These are at least two years from any decision. Our muscle-preserving weight-loss drugs page follows a different branch of research, drugs meant to protect lean mass during weight loss.

Already decided: what is changing in 2027 for approved medicines

Some 2027 changes are already on the calendar. Novo Nordisk announced on February 24, 2026, that the US list price of Wegovy and Ozempic will be $675 a month for all doses from January 1, 2027, roughly half of Wegovy’s earlier list price; it said its direct self-pay prices are not affected. The list price matters most for people whose costs are tied to it, such as those on high-deductible plans. Our Wegovy cost guide has the current self-pay prices.

For people with Medicare, the Medicare GLP-1 Bridge, which began on July 1, 2026, runs through December 31, 2027, with a $50 copay for Foundayo, Wegovy (injection and tablets) and the Zepbound KwikPen when used for weight management. CMS says it extended the program through 2027 to collect more data; it has not said what replaces it in 2028. Medicare open enrollment runs from October 15 to December 7 each year. Our GLP-1 coverage guide explains the rules.

Foundayo itself may gain a second use. Lilly said on June 8, 2026, that it planned to submit Foundayo for type 2 diabetes by the end of the second quarter under a priority voucher, after three ACHIEVE trials. As of October 7, the FDA record shows only the April approval for weight management and an August labeling update, so the diabetes use is not approved.

Devices: two arrivals to know about

On the device side, the newest approval has already happened: the FDA approved the swallowable Allurion gastric balloon on February 20, 2026, and the company reported treating its first US commercial patients in April. The Epitomee capsule, cleared in September 2024, is in a pre-launch program with selected US clinics. Our list of weight-loss devices the FDA has authorized covers both, with their trial results.

What a new approval would and would not change

New medicines bring more choice, but several things stay the same. With every approved GLP-1 medicine so far, weight tends to return after stopping, and our guide on life after a GLP-1 covers what helps. Strength training and enough protein remain important on any strong weight-loss medicine to protect muscle; see muscle loss on GLP-1 medicines. A new label will define who a drug is for, and a launch price and insurance coverage usually lag behind approval.

If you are weighing whether to wait for a new drug, it may help to bring our printable questions to ask before starting a GLP-1 to your clinician, and to compare today’s options with Find My Options. Any FDA decision on the drugs above will appear first in our monthly news roundup, and this page will be updated.

In short: Retatrutide, an investigational weekly injection from Eli Lilly, has now reported results from its main Phase 3 trials, and the numbers are the largest average weight losses seen so far in a medicine trial: in TRIUMPH-1, adults with obesity lost 25.0% of their body weight on the highest dose over 80 weeks, compared with 3.9% on placebo, counting everyone who started. People with type 2 diabetes lost less (18.8% vs 5.1% in TRIUMPH-2). Side effects were mostly digestive, rose with the dose, and included a less familiar skin-sensation effect called dysesthesia. Retatrutide is not FDA approved; Lilly plans to apply in the first quarter of 2027. Checked on October 7, 2026.

This article explains what each Phase 3 trial found, why the same trial can produce two different headline numbers, what the side effects looked like, and what still has to happen before an FDA decision. For the full drug profile, including how the three-hormone design works and the complete list of ongoing trials, see our retatrutide medication page. It is general education, not individual advice.

First, how to read these numbers

Almost every retatrutide headline comes with two different percentages, and both can be correct. They answer different questions.

The treatment-regimen estimand counts everyone who was randomized, including people who stopped the drug early because of side effects or for any other reason. It is the closest a trial gets to “what happens if a group of people is prescribed this”. The efficacy estimand estimates what would have happened if everyone had stayed on the drug as planned. It is useful for understanding the drug’s biological effect, but it is always the bigger number. Lilly’s press releases use the efficacy estimand; its September 29, 2026 release says plainly that “all data in this press release represent the efficacy estimand”. The peer-reviewed papers report both. On this page we lead with the treatment-regimen figures from the journals and label every company figure as company-reported.

• Treatment-regimen (everyone randomized)
• Efficacy estimand (if all stayed on drug)

TRIUMPH-1, obesity, 80 wk25%28.3%

TRIUMPH-2, type 2 diabetes, 80 wk18.8%20.8%

Same trials, two ways of counting: average weight loss on the highest dose (12 mg)

Item	Treatment-regimen (everyone randomized)	Efficacy estimand (if all stayed on drug)
TRIUMPH-1, obesity, 80 wk	25%	28.3%
TRIUMPH-2, type 2 diabetes, 80 wk	18.8%	20.8%

INVESTIGATIONAL. Bars show percent of starting body weight lost. Efficacy-estimand figures are company-reported.

Source: NEJM 2026 and The Lancet 2026 (treatment-regimen); Eli Lilly releases May 21 and Sept 29, 2026 (efficacy estimand) (checked on October 7, 2026)

TRIUMPH-1: adults with obesity, without diabetes

TRIUMPH-1 is the pivotal weight trial, published in the New England Journal of Medicine in September 2026. It enrolled 2,339 adults with obesity, or with overweight and a weight-related health problem, who did not have type 2 diabetes. They were randomly assigned to retatrutide at 4 mg, 9 mg or 12 mg once a week, or to placebo, for 80 weeks, alongside diet and activity counseling. Doses were reached in steps every four weeks, starting at 2 mg.

Counting everyone randomized, average weight change was -17.6% on 4 mg, -23.7% on 9 mg and -25.0% on 12 mg, compared with -3.9% on placebo. By the efficacy estimand, Lilly reported -28.3% on 12 mg. The trial also included 574 people with knee osteoarthritis and 243 with obstructive sleep apnea, and Lilly reported improvements in knee pain and in breathing interruptions during sleep in those groups. In a planned extension for people who started with a BMI of 35 or higher, Lilly reported -30.3% at 104 weeks (efficacy estimand, company-reported).

3.9%Placebo

17.6%Retatrutide 4 mg

23.7%Retatrutide 9 mg

25%Retatrutide 12 mg

TRIUMPH-1: average weight loss at 80 weeks by dose

Item	Value
Placebo	3.9%
Retatrutide 4 mg	17.6%
Retatrutide 9 mg	23.7%
Retatrutide 12 mg	25%

INVESTIGATIONAL: not FDA approved. Treatment-regimen estimand: everyone randomized, including people who stopped. 2,339 adults with obesity and no diabetes.

Source: Jastreboff AM et al., New England Journal of Medicine 2026 (TRIUMPH-1) (checked on October 7, 2026)

One way to put the numbers in context: in the trials that led to approval of today’s leading medicines, average weight loss was 14.9% with semaglutide 2.4 mg (Wegovy) over 68 weeks in STEP 1, and 20.9% with tirzepatide 15 mg (Zepbound) over 72 weeks in SURMOUNT-1. Those were different trials, with different people, lengths and years, so the numbers cannot be compared directly. A direct answer will come from TRIUMPH-5, which tests retatrutide head to head against tirzepatide (see “What comes next” below). Our semaglutide vs tirzepatide comparison explains how the two approved molecules differ.

TRIUMPH-2: adults with type 2 diabetes

TRIUMPH-2, published in The Lancet and presented at the European Association for the Study of Diabetes meeting in September 2026, enrolled 1,152 adults with type 2 diabetes and a BMI of 27 or more for 80 weeks. Counting everyone randomized, weight changed by -11.9% (4 mg), -16.8% (9 mg) and -18.8% (12 mg) vs -5.1% on placebo, and 84% of participants completed treatment. Lilly’s efficacy-estimand figures were -12.7%, -19.1% and -20.8% vs -4.0%.

Blood sugar improved too. From an average HbA1c (a three-month blood sugar measure) of 7.7%, Lilly reported reductions of 1.4 to 1.6 points vs 0.2 on placebo, and 28.4% to 40.0% of people on retatrutide reached an HbA1c below 5.7%, the non-diabetes range, vs 4.4% on placebo (efficacy estimand, company-reported). People with type 2 diabetes usually lose less weight on these medicines than people without it, a pattern also seen with approved GLP-1 medicines. Our guide to type 2 diabetes and weight explains why.

TRIUMPH-3 and TRIUMPH-4: heart disease and knee osteoarthritis

TRIUMPH-3 enrolled about 1,950 adults with a BMI of 35 or more and established cardiovascular disease, with or without diabetes. In its July 23, 2026 topline release, Lilly reported weight changes of -21.6% (9 mg) and -22.6% (12 mg) vs -3.2% on placebo (efficacy estimand). It was not designed to show heart protection: heart attacks, strokes and cardiovascular deaths were fewer than expected in every group, and the hazard ratio of 1.12 (95% confidence interval 0.64 to 1.96) means the trial could not show a difference either way. A separate outcomes trial of about 10,000 people, TRIUMPH-Outcomes, is designed to answer that question; its primary completion is listed for 2029. No full TRIUMPH-3 paper had been published when we checked.

TRIUMPH-4 enrolled 445 adults with obesity or overweight and knee osteoarthritis for 68 weeks. In its December 11, 2025 release, Lilly reported treatment-regimen weight changes of -20.0% (9 mg) and -23.7% (12 mg) vs -4.6%, and knee pain scores that improved by up to 75.8% vs 40.3% on placebo. These results are company-reported and not yet peer reviewed.

Trial	Who took part	Length	Weight change on 12 mg vs placebo	How it was reported
TRIUMPH-1 (NCT05929066)	2,339 adults with obesity, no diabetes	80 weeks	-25.0% vs -3.9%	Peer reviewed (NEJM 2026), treatment-regimen
TRIUMPH-2 (NCT05929079)	1,152 adults with type 2 diabetes	80 weeks	-18.8% vs -5.1%	Peer reviewed (Lancet 2026), treatment-regimen
TRIUMPH-3 (NCT05882045)	About 1,950 adults, BMI 35+, heart disease	80 weeks	-22.6% vs -3.2%	Company topline, efficacy estimand
TRIUMPH-4 (NCT05931367)	445 adults with knee osteoarthritis	68 weeks	-23.7% vs -4.6%	Company topline, treatment-regimen

Side effects: what the trials reported

Because there is no FDA label, the only safety information is what the trials have reported, much of it through company releases. As with the approved GLP-1 medicines, digestive side effects were the most common and rose with the dose. In TRIUMPH-1, Lilly reported nausea in 42.4% of people on 12 mg vs 14.8% on placebo, diarrhea in 32.0% vs 13.5%, constipation in 26.1% vs 10.9% and vomiting in 25.3% vs 4.8%. In TRIUMPH-2, rates were somewhat lower: nausea 28.0% vs 8.0% and vomiting 15.7% vs 4.2% on 12 mg.

• TRIUMPH-1, retatrutide 12 mg
• TRIUMPH-1, placebo
• TRIUMPH-2, retatrutide 12 mg
• TRIUMPH-2, placebo

Nausea42.4%14.8%28%8%

Diarrhea32%13.5%33.6%13.2%

Vomiting25.3%4.8%15.7%4.2%

Dysesthesia (skin sensations)12.5%0.9%7.3%0.7%

Stopped due to side effects11.3%4.9%7.7%4.9%

Reported side effects on the highest dose (12 mg) vs placebo

Item	TRIUMPH-1, retatrutide 12 mg	TRIUMPH-1, placebo	TRIUMPH-2, retatrutide 12 mg	TRIUMPH-2, placebo
Nausea	42.4%	14.8%	28%	8%
Diarrhea	32%	13.5%	33.6%	13.2%
Vomiting	25.3%	4.8%	15.7%	4.2%
Dysesthesia (skin sensations)	12.5%	0.9%	7.3%	0.7%
Stopped due to side effects	11.3%	4.9%	7.7%	4.9%

Company-reported adverse events, not an FDA label table. INVESTIGATIONAL.

Source: Eli Lilly press releases, May 21 and June 6, 2026 (TRIUMPH-1) and Sept 29, 2026 (TRIUMPH-2) (checked on October 7, 2026)

Dysesthesia is the effect that drew the most attention. It means unusual skin sensations, such as tingling, burning or sensitivity to touch. It was reported in 12.5% of TRIUMPH-1 participants on 12 mg vs 0.9% on placebo, 7.3% vs 0.7% in TRIUMPH-2, and 20.9% vs 0.7% in TRIUMPH-4. Lilly says most cases were mild to moderate and resolved during treatment. A similar effect is listed on the label of the approved higher-dose Wegovy HD (22% on 7.2 mg vs 6% on 2.4 mg), but why it happens is not settled, and the FDA review of retatrutide will look at it closely.

Stopping because of side effects rose with dose in TRIUMPH-1 (4.1%, 6.9% and 11.3% vs 4.9% on placebo) and reached 18.2% on 12 mg in TRIUMPH-4. The Phase 2 trial, published in 2023, also showed a dose-dependent rise in heart rate that peaked around week 24. What is not known yet: safety beyond about two years, effects on heart attacks and strokes, rare side effects that only show up in very large groups, and which warnings an eventual label would carry. For the side effects of approved medicines in the same family, see our GLP-1 side effects guide.

What the results do not tell us yet

How it compares with tirzepatide. Only a head-to-head trial can say whether retatrutide leads to more weight loss than tirzepatide, the ingredient in Zepbound, and with what trade-offs. That trial, TRIUMPH-5, has not reported.

What the weight loss is made of. With any large weight loss, some of what is lost is lean mass, which includes muscle. The published abstracts we read do not give body-composition results for the Phase 3 trials, so we cannot say how much of the loss was fat. Our guide to muscle loss on GLP-1 medicines explains why strength training and protein matter on any of these drugs.

What happens after stopping, and long-term heart effects. A maintenance trial (TRIUMPH-6) and the outcomes trial are still running. With approved GLP-1 medicines, weight tends to come back when people stop, and there is no reason yet to expect retatrutide to be different.

Who it would be for, and what it would cost. Neither is known. A label, if the FDA approves one, would define who it is indicated for. There is no price, because it is not on the market.

What comes next

A planned submission is not an approval, and FDA reviews often take many months. When something changes, it will appear in our monthly news roundup and on the emerging medications tracker, which also follows CagriSema, amylin-based drugs and other candidates. For a similar investigational story further along the road, see our CagriSema explainer.

Why not to buy “retatrutide” online

Strong headlines have led to products sold online as “retatrutide”, “reta” or “research peptides”, often labeled “not for human consumption”. Lilly states that retatrutide cannot be legally sold or marketed for human use. The FDA says retatrutide is not a component of any FDA-approved drug and cannot be used in compounding, and it has warned telehealth companies, ingredient distributors and outsourcing facilities over it. Products from these channels have no verified identity, purity, sterility or dose, and the trial results above say nothing about them. We do not link to sellers. Our page on compounded GLP-1s explains how the FDA treats copies of approved drugs, which is a different situation.

If you are interested in treatment now

Several FDA-approved medicines with strong evidence are available today, including weekly injections and daily pills. Our comparison of every FDA-approved weight-loss medication sets their label trials side by side, and our GLP-1 medications guide explains how the class works. If you would like to take part in research, you can search for recruiting studies on ClinicalTrials.gov; most retatrutide trials are no longer recruiting. Before any decision, our printable questions to ask before starting a GLP-1 can help you and your clinician talk through options, and the cost hub covers what approved medicines cost today.

In short: CagriSema is an investigational once-weekly injection that combines cagrilintide, a long-acting amylin receptor agonist, with semaglutide, the ingredient in Wegovy. It is not FDA approved: as of October 6, 2026, there is no FDA approval record or label for it. Novo Nordisk filed for approval in December 2025 and says it expects a decision in the fourth quarter of 2026. In its main trial, average weight change was -20.4% vs -3.0% with placebo over 68 weeks; in a head-to-head trial it lost to tirzepatide (Zepbound).

This explainer covers what CagriSema is, what each trial found, what the side effects looked like, and what an FDA decision would and would not change. For the approved medicines you can use today, see every FDA-approved weight-loss medication compared and our medications hub; for the wider pipeline, see emerging weight-loss medications.

What CagriSema is

Novo Nordisk describes CagriSema as a fixed-dose combination of a long-acting amylin receptor agonist (cagrilintide) and a GLP-1 receptor agonist (semaglutide), injected under the skin once a week. In the main trials, both parts were built up to 2.4 mg each. Semaglutide 2.4 mg on its own is already approved as Wegovy; our GLP-1 guide explains how that half works. Because cagrilintide acts on amylin receptors and semaglutide on GLP-1 receptors, the combination works through two different hormone pathways at once.

Novo is studying it in two programs: REDEFINE for adults with overweight or obesity, and REIMAGINE for adults with type 2 diabetes. A large cardiovascular outcomes trial, REDEFINE 3, is listed with about 7,000 participants, and the company says a higher-dose trial started in 2026.

What the placebo-controlled trials showed

REDEFINE 1 (published in the New England Journal of Medicine in 2025) enrolled 3,417 adults without diabetes who had a BMI of 30 or more, or 27 or more with a weight-related condition. Participants were assigned to CagriSema (2,108 people), semaglutide alone (302), cagrilintide alone (302) or placebo (705), all with lifestyle support, for 68 weeks. Counting everyone as randomized, whether or not they kept taking the drug, average weight change was -20.4% with CagriSema and -3.0% with placebo, a difference of 17.3 percentage points.

REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and a BMI of 27 or more. Average weight change at 68 weeks was -13.7% with CagriSema vs -3.4% with placebo. By the end, 73.5% of people on CagriSema had an HbA1c (a three-month blood sugar measure) of 6.5% or less, compared with 15.9% on placebo. People with type 2 diabetes usually lose less weight on these medicines than people without it, which is also true for approved GLP-1 medicines.

• CagriSema
• Placebo

REDEFINE 1 (no diabetes)20.4%3%

REDEFINE 2 (type 2 diabetes)13.7%3.4%

Average weight change at 68 weeks: CagriSema vs placebo

Item	CagriSema	Placebo
REDEFINE 1 (no diabetes)	20.4%	3%
REDEFINE 2 (type 2 diabetes)	13.7%	3.4%

Treatment-policy estimand (everyone randomized, whether or not they kept taking the drug). Bars show percent weight lost.

Source: Garvey WT et al. and Davies MJ et al., NEJM 2025 (REDEFINE 1 and 2) (checked on October 6, 2026)

You may also see higher numbers, such as the 22.4% Novo cited in September 2026. Companies often report an “if everyone took it as intended” estimate alongside the stricter one. Both are real, but they answer different questions, so check which one a headline uses. On this site we lead with the stricter treatment-policy number when it is published.

Reading CagriSema headlines: a quick guide

• Which estimand? “Treatment policy” or “treatment regimen” counts everyone who was randomized; “trial product” or “efficacy” assumes everyone took the drug as planned and gives a bigger number.
• Compared with what? A result against placebo is not a result against Wegovy or Zepbound. Only REDEFINE 4 and 5 compared CagriSema with an approved medicine directly.
• Who was studied? People with type 2 diabetes, or in East Asian trials, often show different average results.
• Published or announced? A peer-reviewed paper gives full methods and data; a company announcement or conference talk is a first report. We label which is which.
• Approved or expected? “Expected decision” is the company’s timing. Only an FDA action makes a medicine approved.

Head-to-head trials: against semaglutide and tirzepatide

REDEFINE 5 (Lancet Diabetes and Endocrinology, 2026) compared CagriSema with semaglutide 2.4 mg alone in 331 adults in Japan and Taiwan, about a quarter of whom had type 2 diabetes. Assuming the drugs were taken as intended, weight change at 68 weeks was -18.4% with CagriSema vs -11.9% with semaglutide. That suggests the cagrilintide half adds weight loss on top of semaglutide, at least in that population.

REDEFINE 4 was an open-label, 84-week trial in 809 adults with obesity and at least one related condition, comparing CagriSema 2.4/2.4 mg with tirzepatide 15 mg, the top dose of Zepbound. Novo announced in February 2026 that the main goal, showing CagriSema was not worse than tirzepatide, was not met. Average weight change was -20.2% with CagriSema vs -23.6% with tirzepatide counting everyone, or -23.0% vs -25.5% if everyone had stayed on treatment. In people with type 2 diabetes (REIMAGINE 4, 68 weeks), Novo reported in August 2026 that CagriSema was non-inferior to tirzepatide 15 mg on weight (-15.2% vs -15.8% if all adhered) but not on HbA1c.

• CagriSema
• Comparator

REDEFINE 5 vs semaglutide 2.4 mg (68 wk)18.4%11.9%

REDEFINE 4 vs tirzepatide 15 mg (84 wk)20.2%23.6%

Head-to-head trials: CagriSema vs an approved comparator

Item	CagriSema	Comparator
REDEFINE 5 vs semaglutide 2.4 mg (68 wk)	18.4%	11.9%
REDEFINE 4 vs tirzepatide 15 mg (84 wk)	20.2%	23.6%

Different estimands: REDEFINE 5 assumes the drug was taken as intended; REDEFINE 4 bars count everyone randomized. Different trials and populations.

Source: Yamauchi T et al., Lancet Diabetes Endocrinol 2026 (REDEFINE 5); Novo Nordisk company announcement, Feb 23, 2026 (REDEFINE 4, company-reported) (checked on October 6, 2026)

For context on the two molecules it was measured against, see semaglutide vs tirzepatide. REDEFINE 4 results were company-reported at the time we checked; we found no peer-reviewed paper yet.

Side effects in the trials

As with approved GLP-1 medicines, digestive side effects were the most common. In REDEFINE 1, 79.6% of people on CagriSema reported a gastrointestinal adverse event (nausea, vomiting, diarrhea, constipation or abdominal pain) vs 39.9% on placebo; in REDEFINE 2 the figures were 72.5% vs 34.4%. The authors described them as mainly transient and mild to moderate. Novo described CagriSema as well tolerated in REDEFINE 4. There is no FDA label yet, so there is no official list of warnings, boxed warnings or interactions. The approved semaglutide labels give a sense of what regulators look at; our GLP-1 side effects guide covers those.

• CagriSema
• Placebo

REDEFINE 179.6%39.9%

REDEFINE 272.5%34.4%

People reporting a digestive (GI) adverse event

Item	CagriSema	Placebo
REDEFINE 1	79.6%	39.9%
REDEFINE 2	72.5%	34.4%

Mostly transient and mild to moderate, per the trial authors.

Source: Garvey WT et al. and Davies MJ et al., NEJM 2025 (checked on October 6, 2026)

Newer data from September 2026

At the European Association for the Study of Diabetes meeting on September 30, 2026, Novo presented a 52-week brain-imaging (fMRI) study showing changes in brain responses to high-calorie food cues, which it linked to fewer cravings (“food noise”), plus REIMAGINE 1 (189 adults with type 2 diabetes, 40 weeks) and REIMAGINE 2 (2,713 adults, 68 weeks) results on body fat, organ fat and bone. These were company-reported conference findings; we will add details once full papers are published.

CagriSema timeline so far

When	What happened	Source type
2025	REDEFINE 1 and REDEFINE 2 results published in the New England Journal of Medicine	Peer-reviewed trials
December 2025	Novo Nordisk files a New Drug Application with the FDA for weight management, based on REDEFINE 1 and 2	Company-reported
2026	REDEFINE 5 (vs semaglutide, Japan and Taiwan) published in Lancet Diabetes and Endocrinology	Peer-reviewed trial
February 23, 2026	REDEFINE 4 headline results: main goal against tirzepatide not met	Company-reported
August 2026	REIMAGINE 4 (type 2 diabetes, vs tirzepatide) reported in Novo’s half-year report	Company filing (SEC Form 6-K)
September 30, 2026	New data at the EASD meeting; decision still expected in Q4 2026	Company-reported
Q4 2026 (expected)	FDA decision	Company expectation, not an FDA date

Who took part in the trials

Knowing who was studied helps you judge how the results might apply. REDEFINE 1 included adults without diabetes with a BMI of 30 or higher, or 27 or higher with at least one obesity-related condition. REDEFINE 2 was run in 12 countries in adults with type 2 diabetes, a BMI of 27 or more and an HbA1c between 7% and 10%, assigned three to one to CagriSema or placebo. REDEFINE 5 used Japanese obesity criteria: a BMI of at least 27 with two or more obesity-related conditions, or at least 35 with one; 68% of its participants were men. REDEFINE 4 enrolled 809 adults with obesity and at least one related condition, with an average starting weight of 114.2 kg (about 252 lb). Everyone in these trials also received lifestyle support, which is why the placebo groups lost some weight too.

What we still do not know

• Heart outcomes. REDEFINE 3, a cardiovascular outcomes trial of about 7,000 people, is still running. Semaglutide alone has shown a heart-risk benefit (the basis of Wegovy’s cardiovascular indication), but that cannot be assumed for the combination.
• Longer-term safety. The main trials lasted 68 to 84 weeks. An FDA label would summarize the safety data the agency reviewed, including any warnings.
• What happens after stopping. With approved GLP-1 medicines, much of the weight tends to return after stopping; CagriSema results on this have not been published.
• Body composition. Novo has presented data on body fat and organ fat, but full papers were not out when we checked.
• Price and coverage. Nothing official exists until a medicine is approved and launched.

What the FDA decision means

An FDA review checks whether the trial evidence shows a medicine is effective for a specific use and that its benefits outweigh its risks for the people on the label. If the FDA approves CagriSema, it would publish a label stating exactly who it is for (likely based on REDEFINE 1 and 2, the trials Novo says the filing used), the dose steps, warnings and side-effect rates. The FDA could also ask for more information, which would delay a decision. Until a decision is announced, any launch date or price you see is speculation.

Approval would not change three things: the medicine would still need a prescription, coverage for weight medicines would still vary widely (see our insurance guide), and like other weight medicines it would be meant for long-term use alongside eating and activity changes. Strength training and enough protein help protect muscle on any of these medicines, as our muscle loss guide explains.

How it compares with what is approved today

It is tempting to line CagriSema up against approved medicines, but only REDEFINE 4 and REDEFINE 5 were true head-to-head trials. For reference, in their own placebo-controlled trials Wegovy (STEP 1) averaged -14.9% at 68 weeks and Zepbound 15 mg (SURMOUNT-1) -20.9% at 72 weeks, with different people and designs. Another investigational medicine, retatrutide, has also reported Phase 3 results and is expected to be filed in 2027. Our Wegovy vs Zepbound page explains how to read trial numbers like these.

Can you get CagriSema now?

Only by taking part in a clinical trial. ClinicalTrials.gov lists Novo’s CagriSema studies, and a trial team can tell you whether you are eligible. Anything sold online as CagriSema or cagrilintide outside a trial is not an approved medicine. The FDA has warned that compounded or “research use” versions of unapproved ingredients can contain the wrong amount, the wrong substance or contaminants; our compounded GLP-1 guide explains the risks. We will update this page within a week of any FDA action, and the monthly weight-loss news roundup tracks the decision date.