New Weight Loss Drugs Coming Out: Ranked by FDA Approval Status

Only one new weight-loss drug is actually sitting at the FDA right now: CagriSema, a once-weekly injection from Novo Nordisk, whose application was submitted on December 18, 2025, with FDA review expected during 2026 ^[1]. The next closest is retatrutide, Eli Lilly’s triple hormone drug, which has five positive Phase 3 studies in hand and a filing planned for Q1 2027 ^[2]. After that comes survodutide, Boehringer Ingelheim’s dual agonist, which announced positive Phase 3 weight-loss results in April 2026 but has not announced a US filing ^[3]. Everything else in the pipeline — MariTide, VK2735, and a wave of others — has registered trial records on ClinicalTrials.gov, which places them at the back of the milestone order this page uses to rank drugs ^{[4][5][6][7][8][9][10][11]}.

This page ranks drugs by how close they are to approval, not by how much weight people lost in trials. That distinction matters. A drug with a finished Phase 3 trial is not automatically close to market, and a drug with a smaller headline percentage is not automatically worse. Trial results come from different starting weights, different populations, and different statistical methods, so cross-trial comparisons of weight-loss percentages are not valid ^[1][2][3].

How the ranking works: filings beat trial results

The order here follows regulatory milestones, from closest to furthest ^[1][2]:

1. Application submitted. The drug is under active FDA review. Only CagriSema is here ^[1].
2. Filing date announced. The company has publicly committed to a submission window. Retatrutide is here, with a BLA planned for Q1 2027 ^[2].
3. Phase 3 data in hand, no filing announced. Survodutide is here ^[3].
4. Trials registered and running. Results do not exist yet in public form ^{[4][5][6][7][8][9][10][11]}.

One detail worth knowing about retatrutide: Lilly has said its filing is gated by completing the Chemistry, Manufacturing and Controls (CMC) data package, not by waiting for more trial results. The clinical data package is already sufficient, per the company ^[2]. That means manufacturing paperwork, not science, is the current pacing item.

A second detail explains a lot of confusing headlines. Trials report two different numbers using what are called estimands, and companies name them differently. Novo Nordisk’s release calls its higher figure the trial product estimand — the effect in an idealized scenario in which all patients stayed on treatment and took no other weight-loss therapies — and its lower figure the treatment policy estimand, the effect regardless of whether patients stayed on treatment or took other therapies ^[1]. Lilly uses the term efficacy estimand for the comparable idea: efficacy had all randomized participants remained on the study intervention without starting other weight-management treatments ^[2]. In REDEFINE 1, the only trial on this page where both figures have been published, the stay-on-treatment figure was higher: 22.7% versus 20.4% ^[1]. When a trial reports two percentages for the same result, the estimand difference is usually the reason — not a correction or a dispute.

CagriSema: the only new obesity drug under FDA review

CagriSema is a fixed-dose once-weekly injection combining cagrilintide 2.4 mg (a long-acting amylin analog) with semaglutide 2.4 mg (a GLP-1 receptor agonist). Novo Nordisk submitted the NDA on December 18, 2025, for chronic weight management in adults with obesity, or overweight with at least one weight-related condition, used with a reduced-calorie diet and increased physical activity ^[1]. If approved, it would be the first injectable combination of a GLP-1 receptor agonist and an amylin analog ^[1].

The application is built on the REDEFINE program. In REDEFINE 1, a 68-week trial in 3,417 adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one complication and no diabetes, people taking CagriSema lost 22.7% of body weight at 68 weeks versus 2.3% for placebo under the trial product estimand ^[1]. Under the treatment policy estimand, the figure was 20.4% versus 3.0% for placebo, from an average baseline weight of about 236 lb ^[1].

Other REDEFINE 1 results, all under the treatment policy estimand ^[1]:

• 91.9% of CagriSema participants lost at least 5% of body weight, versus 31.5% on placebo.
• In a supportive secondary analysis, 54% of participants who had obesity at baseline dropped below BMI 30 by week 68, versus 11.1% on placebo.
• REDEFINE 2 studied 1,206 adults with type 2 diabetes and obesity or overweight over 68 weeks against placebo.

Side effects were mostly gastrointestinal. In REDEFINE 1, adverse events occurred in 79.6% of the CagriSema group versus 39.9% on placebo, including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%), and vomiting (26.1% vs 4.1%). Discontinuation due to adverse events was 5.9% versus 3.5% on placebo in REDEFINE 1, and 8.4% versus 3% in REDEFINE 2 ^[1].

Two things to keep in mind. First, the FDA is expected to review the application in 2026, but no decision date has been disclosed in the company’s release, so there is no way to state when an approval decision will land ^[1]. Second, CagriSema is not approved in the US or the EU, and ongoing trials — including REDEFINE 3, a cardiovascular outcomes trial (NCT05669755), and REDEFINE 11, a longer-duration study — are still running ^[1].

Retatrutide: the next filing, planned for Q1 2027

Retatrutide is Eli Lilly’s once-weekly single molecule that activates three receptors: GIP, GLP-1, and glucagon. Lilly announced on July 23, 2026 that it plans to submit a Biologics License Application to the FDA in Q1 2027, and says its data package now supports submissions for obesity, knee osteoarthritis pain, and obstructive sleep apnea ^[2].

The company counts five positive Phase 3 studies to date. The two most recent readouts ^[2]:

Trial	Population	Result at 80 weeks (efficacy estimand)
TRIUMPH-2 (NCT05929079)	1,152 adults with type 2 diabetes and obesity or overweight	-12.7% (4 mg), -19.1% (9 mg), -20.8% (12 mg) vs -4.0% placebo
TRIUMPH-3 (NCT05882045)	1,949 adults with BMI ≥35 and established cardiovascular disease	-21.6% (9 mg), -22.6% (12 mg) vs -3.2% placebo

In TRIUMPH-2, the 12 mg dose averaged 49.6 lb lost, with A1C reductions up to 1.6% from a baseline of 7.7% ^[2]. In TRIUMPH-3, the 12 mg dose averaged 55.8 lb lost, and the highest dose delivered reductions of 37.0% in triglycerides, 16.5% in non-HDL cholesterol, 9.3 mmHg in systolic blood pressure, 19.0 cm in waist circumference, and 51.2% in high-sensitivity CRP ^[2].

Cardiovascular events in TRIUMPH-3 were less frequent than anticipated in both arms. For the pre-specified MACE-5 analysis, the hazard ratio was 0.82 (95% CI 0.55–1.22), based on 44 events in the pooled retatrutide arms versus 52 on placebo. For MACE-3, the hazard ratio was 1.12 (95% CI 0.64–1.96) ^[2]. Both confidence intervals cross 1.0, meaning neither a benefit nor a harm was statistically established.

Discontinuation due to adverse events ran higher than placebo in most arms: 3.8% (4 mg), 11.6% (9 mg), and 7.7% (12 mg) versus 4.9% placebo in TRIUMPH-2, and 9.8% (9 mg) and 13.5% (12 mg) versus 4.8% placebo in TRIUMPH-3 ^[2]. A side effect called dysesthesia — altered skin sensation — appeared in 4.5% to 7.3% of retatrutide arms in TRIUMPH-2 and 6.4% in both retatrutide arms in TRIUMPH-3, versus 0.7% and 1.3% on placebo; Lilly says these events were generally mild to moderate and mostly resolved during treatment ^[2]. Dosing starts at 2 mg weekly and steps up every four weeks to a target of 4, 9, or 12 mg ^[2].

The TRIUMPH program began in 2023 and has enrolled more than 5,800 participants across four global registrational trials ^[2]. Retatrutide is investigational and cannot legally be sold or marketed for human use ^[2].

Survodutide: first Phase 3 results reported, no US filing announced

Survodutide (BI 456906) is a glucagon/GLP-1 dual agonist licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for global development and commercialization ^[3]. On April 28, 2026, the company announced topline results from SYNCHRONIZE-1, a 76-week Phase 3 trial in 725 adults with obesity or overweight without type 2 diabetes, receiving weekly 3.6 mg, 6.0 mg, or placebo ^[3].

Participants lost up to an average of 16.6% after 76 weeks under the efficacy estimand, versus 3.2% on placebo (p<0.0001), with average losses up to 39.2 lb (17.8 kg) ^[3]. The other co-primary endpoint was also met: up to 85.1% of adults treated with survodutide achieved at least 5% weight reduction versus 38.8% on placebo (p<0.0001) ^[3]. Initial analysis indicates the weight loss was driven predominantly by fat tissue, with lean mass contributing only a small proportion, and waist circumference fell significantly as a key secondary endpoint ^[3].

Gastrointestinal events occurred as expected for the GLP-1 class, with discontinuations more frequent during dose escalation; events were mild to moderate and temporary, with no new safety signals beyond the class ^[3].

What keeps survodutide out of the number-two spot is the absence of any announced US filing for obesity. Full SYNCHRONIZE-1 data will be presented at the ADA 2026 Scientific Sessions in June, and additional trial readouts are expected during 2026 ^[3]. The broader program includes SYNCHRONIZE-2 (type 2 diabetes), SYNCHRONIZE-MASLD, SYNCHRONIZE-CVOT, and the in-market SYNCHRONIZE-JP and SYNCHRONIZE-CN trials, plus the LIVERAGE trials in MASH — LIVERAGE (about 1,800 adults, NCT06632444) and LIVERAGE-Cirrhosis (about 1,590 adults, NCT06632457), both with a maximum dose of 6 mg weekly ^[3].

Survodutide has received FDA Fast Track designation (May 2021) and Breakthrough Therapy designation (September 2024), but those designations are for MASH with fibrosis stages 2–3, not for obesity ^[3]. Designations are not approvals. Survodutide has not been approved for use, and its efficacy and safety are not established ^[3].

What other weight-loss drugs have registered trials

Beyond the three front-runners, a long list of drugs has registered trials on ClinicalTrials.gov. These are the trials a reader will encounter when searching the pipeline.

Drug	Registered trial record	Population studied
Maridebart cafraglutide (MariTide)	NCT06858839	Adults without type 2 diabetes who have obesity or are overweight [4]
VK2735 injection	NCT07104500	Weight management; the record is titled a Phase 3 study [5]
Aleniglipron	NCT07654361	Study details not shown in the record listed here [6]
Eloralintide (LY3841136)	NCT07321886	Obesity, or overweight without type 2 diabetes [7]
Elecoglipron	NCT07667803	Obesity or overweight, with or without type 2 diabetes (master protocol) [8]
Ribupatide	NCT07284875	Obesity or overweight with weight-related comorbidities, without diabetes [9]
Berobenatide (PF-08653944)	NCT07595549	Overweight or obesity [10]
Zenagamtide	NCT07668414	Head-to-head versus semaglutide for weight loss [11]

A registered trial means the study exists and is planned or underway — not that results exist. These records are trial registrations; whether a sponsor has filed with the FDA is not something these registry pages show ^[4][5]. Boehringer is also advancing BI 3034701, a triple GLP-1/GIP/NPY2 receptor agonist entering Phase 2 in mid-2026, plus oral options, which sit even further back in the pipeline ^[3].

Can you get an investigational drug before approval?

There are two legal routes: a clinical trial, or expanded access. Expanded access — also called compassionate use — is a pathway for patients with serious diseases or conditions who cannot join a trial to obtain a product the FDA has not approved ^[4].

There are three types ^[4]:

• Individual Patients — access for a single patient, including emergencies.
• Intermediate-size Population — access for more than one patient but generally fewer than a Treatment IND covers.
• Treatment IND/Protocol — access for a large population, only when the product is already being developed for marketing for that same use.

On ClinicalTrials.gov, expanded access records carry a status. “Available” means patients who are not trial participants may be able to obtain the drug; “Temporarily not available” and “No longer available” are distinct statuses with different meanings ^[4]. A retatrutide expanded access record exists at NCT07629401, but its current status and eligibility criteria should be verified directly on that record before relying on it ^[12].

Expanded access is not a route around the approval process. Lilly states that retatrutide cannot legally be sold or marketed for human use ^[2], and Boehringer states survodutide has not been approved for use ^[3].

How to read the ClinicalTrials.gov terms you will hit

If you look up any of the trials above, a few terms drive most of the confusion ^[4][5]:

• Primary completion date. This is when the main data collection ends, and it starts the results-reporting clock — results are generally due one year later, with exceptions ^[4].
• Estimated enrollment. This is the target number of participants, not the number actually enrolled ^[4].
• Certification. A sponsor seeking FDA approval can delay submitting results up to 2 years via certification, which is why a finished trial can stay quiet for a long time ^[4].
• Arm types. An experimental arm receives the drug being studied; an active comparator arm receives a treatment already considered effective; a placebo comparator arm receives an inactive treatment ^[5].

These terms explain why a trial can look “done” while nothing public has been published, and why two records for the same drug can show very different numbers.

What if you want help now, not in 2027?

Every drug on this page except the approved ones is investigational, meaning its efficacy and safety are not established. Survodutide’s own sponsor states plainly that it has not been approved for use and its efficacy and safety are not established ^[3], and retatrutide cannot legally be sold or marketed for human use ^[2].

Approved options named in these sources include Zepbound (tirzepatide) and Foundayo (orforglipron), both from Lilly ^[2]. Foundayo is for adults with obesity, or overweight with weight-related medical problems, and should not be used with other GLP-1 receptor agonist medicines ^[2]. It carries a boxed warning about thyroid C-cell tumor risk, is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, and carries a pancreatitis warning ^[2].

Waiting for a pipeline drug means waiting through filing, review, and — for most of the list above — trial completion first. Anyone considering treatment now has approved options to discuss with a clinician, and anyone curious about the pipeline can track the milestones above: filing submitted, filing announced, data in hand, trials running.

Sources

1. PR Newswire. Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management.
2. PR Newswire. Lilly’s triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C. July 23, 2026.
3. Boehringer Ingelheim. Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% in Phase III SYNCHRONIZE-1 obesity trial. April 28, 2026.
4. ClinicalTrials.gov. Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (NCT06858839).
5. ClinicalTrials.gov. VK2735 for Weight Management Phase 3 (NCT07104500).
6. ClinicalTrials.gov. Clinical study record NCT07654361.
7. ClinicalTrials.gov. A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes (NCT07321886).
8. ClinicalTrials.gov. A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM (NCT07667803).
9. ClinicalTrials.gov. Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes (NCT07284875).
10. ClinicalTrials.gov. A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity (NCT07595549).
11. ClinicalTrials.gov. A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide (NCT07668414).
12. ClinicalTrials.gov. Clinical study record NCT07629401.
13. RTTNews. Novo Nordisk And United Lab Reports Positive Results From Chinese Phase 2 Trial Of UBT251 In Obesity.
14. flcube.com. United Laboratories Novo Nordisk Report Positive Phase II Data for UBT251 - Triple GLP-1/GIP/GCG Agonist Achieves 19.7% Weight Loss.