The Retatrutide File

Category: Basics

Not approvedInvestigational

What is retatrutide? The peptide, the trials and where it stands

A once-weekly injected peptide from Eli Lilly that acts on three hormone receptors at once. Six phase 3 trials have reported. No regulator has approved it.

Published Last checked By The Retatrutide File desk

Where retatrutide stands, as of Nov 12, 2026

  1. Completed: Phase 1 Done
  2. Completed: Phase 2 Done
  3. Current stage: Phase 3 Under way
  4. Next step, not reached: FDA filing Planned Q1 2027
  5. Not reached: FDA decision No date
  6. Not reached: Pharmacies No date
Retatrutide at a glance. One peptide acting on three receptors: GLP-1, GIP and glucagon. Maker: Eli Lilly, code LY3437943. Status: not approved, in phase 3, with 6 phase 3 trials reported. Average weight change at the 12 mg dose versus placebo, from peer-reviewed papers that count everyone assigned, bars to scale: TRIUMPH-1, 80 weeks, 25.0% versus 3.9%; TRIUMPH-4, 68 weeks, 23.7% versus 4.6%; TRIUMPH-2 with type 2 diabetes, 80 weeks, 18.8% versus 5.1%; TRANSCEND-T2D-1 with type 2 diabetes, 40 weeks, 15.3% versus 2.6%. FDA filing planned for Q1 2027; whether it is filed as a drug or a biologic is disputed in court. FDA decision and pharmacies: no date.
Graphic built from the figures in this article.

What is retatrutide? It's an experimental drug from Eli Lilly for obesity and type 2 diabetes, given as an injection once a week. It is a single peptide that switches on three hormone receptors at once: GLP-1, GIP and glucagon. Retatrutide is not approved by the FDA or any other regulator, and Lilly says it will file for FDA approval in the first three months of 2027 [Lilly, Sep 29, 2026]. In the peer-reviewed phase 3 trials, people on the top dose lost about 15% to 25% of their body weight on average, depending on the trial.

That's the short answer. Below, you'll find what kind of drug it is and what it's being tested for. Then come the trial results, with who reported each number, the main side effects and the only legal ways to get it today. Every claim carries a source tag and a date.

What kind of drug is retatrutide?

Retatrutide is a peptide: a short chain of amino acids, built in a lab. Lilly describes it as an investigational once-weekly triple hormone receptor agonist and a single molecule [Lilly, Oct 2026]. An agonist is a molecule that switches a receptor on. Retatrutide switches on three:

  • GLP-1, the receptor semaglutide (Wegovy, Ozempic) acts on.
  • GIP, the second receptor tirzepatide (Zepbound, Mounjaro) acts on.
  • Glucagon, the new part. Neither semaglutide nor tirzepatide targets it.

In Lilly's lab work, the GLP-1 and GIP effects cut how much the animals ate, and the glucagon effect added a rise in the energy they burned [Cell Metabolism, 2022]. Glucagon on its own makes the liver release sugar [Lilly Medical, Oct 6, 2025], which is one reason researchers watch it closely.

So is retatrutide a GLP-1? Partly. It acts on the GLP-1 receptor, but it is not a GLP-1 drug in the way semaglutide is, because two other receptors are in play. That's why Lilly calls it a "triple agonist." For a plain-words walk through each receptor, see how retatrutide works.

In trials, people inject it under the skin once a week [Lilly, Oct 2026]. The weekly schedule comes from early testing: in a 12-week phase 1 study, the drug's half-life was about 6 days, which the authors said suits once-weekly dosing [Lancet, 2022].

Is it a drug or a biologic? That is disputed. Lilly plans to file a Biologics License Application, the form used for biologics [Lilly, Sep 29, 2026]. But in March 2024 the FDA classified retatrutide as a drug, not a biological product. The argument is over size. FDA rules define a protein as greater than 40 amino acids in size. Retatrutide's main chain has 39 amino acids, and the side chain that holds its fatty acid adds two more. Lilly counts 41. The FDA counts 40, because one side-chain unit is not an alpha amino acid, the type its rule counts [7th Cir. brief, Apr 1, 2026]. On Oct 2, 2026, the FDA again rejected Lilly's argument, and Lilly's appeal was undecided when we checked on Nov 12, 2026 [7th Cir. filing, Oct 8, 2026].

Who makes retatrutide, and does it have a brand name?

Eli Lilly and Company is developing it [Lilly, Oct 2026], and Lilly scientists published its discovery in 2022 [Cell Metabolism, 2022]. In papers and trial records it often appears under its development code, LY3437943 [NEJM, 2023]. The first people received it in a Lilly safety study that started in March 2019 [ClinicalTrials.gov, NCT03841630].

There is no brand name yet. As of Nov 12, 2026, Lilly's retatrutide pages and releases use only the generic name [Lilly, Oct 2026]. So a brand name printed on a product sold online is not Lilly's.

Is retatrutide a "GLP-3"?

No. "GLP-3" is a nickname that spread on social media because the drug hits three receptors. There is no GLP-3 hormone and no GLP-3 drug class. Lilly's own answer is blunt: the term is a scientifically inaccurate label used informally in the media, and triple agonist is the accurate description [Lilly, Oct 2026].

What is retatrutide used for? What it's being tested for

It isn't used for anything yet outside research, because it isn't approved. What it is being tested for is a long list. Lilly's phase 3 trials cover obesity, type 2 diabetes and knee osteoarthritis pain. They also cover moderate to severe obstructive sleep apnea, chronic low back pain, heart and kidney outcomes, and fatty liver disease (MASLD) [Lilly, Oct 2026]. The trial registry backs that up:

Condition Main trials Where they stand on Nov 12, 2026
Obesity or overweight TRIUMPH-1, TRIUMPH-3 Completed; results published or reported
Obesity with type 2 diabetes TRIUMPH-2 Completed; paper in The Lancet
Type 2 diabetes TRANSCEND-T2D-1, TRANSCEND-T2D-2 First completed; second reported main results, extension running
More obesity trials, including against tirzepatide TRIUMPH-5, -6, -8, -9 Running, not recruiting; no results yet
Knee osteoarthritis pain TRIUMPH-4, TRIUMPH-1 substudy Completed; paper in NEJM
Obstructive sleep apnea TRIUMPH-1 and TRIUMPH-2 substudies Completed; paper in NEJM
Heart and kidney outcomes NCT06383390, about 10,000 people Running, not recruiting; main results expected 2029
Fatty liver disease (MASLD) NCT07165028 Recruiting
Chronic low back pain TRIUMPH-7 Running, not recruiting

Sources: [ClinicalTrials.gov, Nov 12, 2026] [ClinicalTrials.gov, NCT06383390] [ClinicalTrials.gov, NCT07165028]. On Nov 12, 2026, ClinicalTrials.gov listed 33 studies of retatrutide: 21 completed, 9 active but no longer recruiting, 2 recruiting and 1 expanded access program [ClinicalTrials.gov, Nov 12, 2026].

What have the trials found?

The first phase 3 result arrived in December 2025, from TRIUMPH-4 [Lilly, Dec 11, 2025]. Six phase 3 trials have now reported. The headline is weight loss. Across the trials, people taking the highest dose tested, 12 mg once a week, lost far more weight than people on placebo. Here are the main results, each with the trial's own population and length. The FDA filing guide covers the retatrutide clinical trials still under way, and the results guide sets out retatrutide weight loss results trial by trial.

The first table gives the figure each phase 3 paper leads with, which counts everyone assigned to the drug, including people who stopped:

Trial Who was in it Dose, length Average weight change, everyone counted Placebo Source type
TRIUMPH-1 2,339 adults with obesity or overweight, no diabetes 12 mg, 80 weeks −25.0% −3.9% Peer-reviewed paper [NEJM, Sep 29, 2026]
TRIUMPH-4 445 adults with obesity and knee osteoarthritis 12 mg, 68 weeks −23.7% −4.6% Peer-reviewed paper [NEJM, Nov 8, 2026]
TRIUMPH-2 1,152 adults with obesity and type 2 diabetes 12 mg, 80 weeks −18.8% −5.1% Peer-reviewed paper [Lancet, Sep 29, 2026]
TRANSCEND-T2D-1 537 adults with type 2 diabetes, on diet and exercise 12 mg, 40 weeks −15.3% −2.6% Peer-reviewed paper [Lancet, Jun 6, 2026]

Three more results exist only as Lilly's "efficacy estimand," explained below. That figure assumes everyone stayed on the drug, so it runs higher, and it can't be set beside the table above:

Trial Who was in it Dose, length Average weight change if everyone had stayed on the drug Placebo or comparator Source type
Phase 2 338 adults with obesity or overweight 12 mg, 48 weeks −24.2% −2.1% Peer-reviewed paper; Lilly says it used this estimand [NEJM, 2023] [Lilly, Jun 26, 2023]
TRIUMPH-3 1,949 adults with severe obesity and heart disease 12 mg, 80 weeks −22.6% −3.2% Company press release, not yet peer reviewed [Lilly, Jul 23, 2026]
TRANSCEND-T2D-2 1,298 adults with type 2 diabetes, on metformin 12 mg, 80 weeks −20.9% −9.4% on semaglutide 2 mg Company press release, not yet peer reviewed [Lilly, Oct 28, 2026]

Why do you see two different numbers for the same trial? For TRIUMPH-1, Lilly's May press release said 28.3%, compared with 2.2% on placebo [Lilly, May 21, 2026]. The NEJM paper reports 25.0% compared with 3.9% [NEJM, Sep 29, 2026]. Both are correct. The 28.3% estimates what would have happened if everyone had stayed on the drug. The 25.0% counts everyone who was assigned to it, including people who stopped. The second number is closer to what a group of real patients might see, which is why this page leads with it.

Two patterns stand out. People with type 2 diabetes lost less weight: 18.8% on 12 mg in TRIUMPH-2 [Lancet, Sep 29, 2026], against 25.0% in TRIUMPH-1, both over 80 weeks [NEJM, Sep 29, 2026]. And the extra conditions moved too: knee pain scores fell more than on placebo [NEJM, Nov 8, 2026], and so did breathing pauses during sleep in people with sleep apnea [NEJM, Oct 21, 2026]. Blood sugar fell as well. In TRANSCEND-T2D-1, adults with type 2 diabetes on 12 mg saw their A1C drop by 1.94 percentage points over 40 weeks, compared with 0.81 on placebo [Lancet, Jun 6, 2026]. A1C is the standard measure of average blood sugar over the past few months. The benefits guide grades each of these retatrutide benefits by the strength of its evidence.

What are the main side effects?

The common ones are digestive: nausea, diarrhea, vomiting and constipation, mostly mild to moderate and more frequent at higher doses [NEJM, 2023]. In TRIUMPH-1, nausea affected 42.4% of people on 12 mg, compared with 14.8% on placebo. Side effects led 11.3% of people on 12 mg to stop the drug, compared with 4.9% on placebo [Lilly, May 21, 2026].

Two signals get extra attention. One is dysesthesia, an odd or painful sensitivity of the skin, reported in 12.5% of people on 12 mg in TRIUMPH-1, compared with 0.9% on placebo [Lilly, May 21, 2026]. The other is heart rate: in the phase 2 trial, heart rate rose with the dose, peaked at 24 weeks and then came down [NEJM, 2023]. The full list, trial by trial, is in retatrutide side effects, and the doses each trial tested are in retatrutide dosage in trials.

Is retatrutide approved, and when could it be?

No. Retatrutide is not approved by the FDA or any regulator in the world [Lilly, Oct 28, 2026]. It hasn't even been filed yet. In September, Lilly put its plan in one sentence: Lilly plans to submit a Biologics License Application (BLA) in Q1 2027 to the U.S. Food and Drug Administration. [Lilly, Sep 29, 2026]

Even the type of application is disputed. The FDA has classified retatrutide as a drug, not a biologic, and Lilly's appeal was undecided on Nov 12, 2026, as explained above [7th Cir. filing, Oct 8, 2026]. Lilly told the court it needs to know which application pathway (biological product or drug) to pursue when filing [7th Cir. filing, Oct 8, 2026].

Before filing, Lilly said in July, it is completing the chemistry, manufacturing and controls data package the application needs [Lilly, Jul 23, 2026]. It also said the data support submissions around the world for obesity, knee osteoarthritis pain and obstructive sleep apnea [Lilly, Jul 23, 2026].

A filing starts an FDA review. It is not an approval, and no FDA decision date can exist before Lilly files. That's why the status rail near the top of this page shows "no date" for the FDA decision and for pharmacies. The retatrutide FDA approval timeline explains how long a review usually takes and what could change it. No price exists either; the retatrutide cost guide covers what is known about money and insurance.

How can you get retatrutide legally today?

Only two ways.

A clinical trial. Trial drugs are given to enrolled volunteers under a study protocol. On Nov 12, 2026, one Lilly retatrutide trial was recruiting: a phase 3 study in fatty liver disease. People in it are assigned by chance to retatrutide, tirzepatide or placebo [ClinicalTrials.gov, NCT07165028]. The only other "recruiting" record is a study at one site in China whose sponsor isn't Lilly. We couldn't verify it, so we don't count it as a route [ClinicalTrials.gov, Nov 12, 2026]. Most other trials have finished enrolling.

Lilly's expanded access program. This is for a narrow group. Adults qualify only if their BMI stays at 35 or above even on the top available dose of a weight-management medicine. They also need two or more serious complications of obesity, and no way into a trial [ClinicalTrials.gov, NCT07629401]. You can't apply yourself. The treating doctor contacts Lilly, and the registry record tells patients to go through their doctor [ClinicalTrials.gov, NCT07629401].

There is no third route. Retatrutide is not on the market, and no one can legally sell it for human use [Lilly, Oct 2026]. The FDA says retatrutide cannot be used in compounding under federal law [FDA, Oct 1, 2026]. The FDA has also warned companies selling it as a product for research purposes or not for human consumption [FDA, Oct 1, 2026]. Lilly's position is plain: Anyone purporting to sell retatrutide to consumers is breaking the law. [Lilly, Oct 28, 2026] The buying guide, retatrutide for sale, explains what those online listings are and what tests of them found.

How does retatrutide compare with drugs you can get now?

The two drugs retatrutide is most often compared with are already approved for chronic weight management. Semaglutide, sold as Wegovy, is a GLP-1 receptor agonist [Wegovy label, Jun 2026] and was approved for weight in June 2021 [FDA, Jun 2021]. Tirzepatide, sold as Zepbound, acts on GLP-1 and GIP and was approved for weight in November 2023 [FDA, Nov 8, 2023]. Retatrutide adds the glucagon receptor on top of those two.

Retatrutide's trial numbers look larger than the older drugs' trial numbers, but those trials enrolled different people, at different times, for different lengths. They can't be lined up as a contest. One head-to-head trial has reported: in TRANSCEND-T2D-2, adults with type 2 diabetes lost 20.9% on retatrutide 12 mg, compared with 9.4% on semaglutide 2 mg, over 80 weeks. That figure comes from Lilly's press release and is not yet peer reviewed [Lilly, Oct 28, 2026]. A head-to-head trial against tirzepatide, TRIUMPH-5, is still running, with no results posted [ClinicalTrials.gov, NCT06662383]. For side-by-side detail, see retatrutide vs tirzepatide and retatrutide vs semaglutide.

The practical difference is simpler. Wegovy and Zepbound can be prescribed today. Retatrutide can't, and won't be until a regulator approves it.

Sources

  1. [Lilly, Oct 2026] What to know about retatrutide. Eli Lilly and Company (page marked last updated October 2026), Oct 2026. Company page. Checked Nov 12, 2026
  2. [Lilly Medical, Oct 6, 2025] What is the mechanism of action of retatrutide?. Lilly Medical (US medical information), date of last review Oct 6, 2025, Oct 6, 2025. Company page (medical information). Checked Nov 12, 2026
  3. [Cell Metabolism, 2022] LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Cell Metabolism (Coskun T et al., Eli Lilly), Aug 18, 2022. Peer-reviewed paper (animal and early human studies). Checked Nov 12, 2026
  4. [Lancet, 2022] LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. The Lancet (Urva S et al.), Oct 27, 2022. Peer-reviewed paper. Checked Nov 12, 2026
  5. [ClinicalTrials.gov, NCT03841630] A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants. ClinicalTrials.gov, sponsor Eli Lilly and Company, Mar 13, 2019. Trial registry record. Date shown is the study start. 45 participants; completed Jul 25, 2019. Checked Nov 12, 2026
  6. [NEJM, 2023] Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial. New England Journal of Medicine (Jastreboff AM et al.), Jun 26, 2023. Peer-reviewed paper. Checked Nov 12, 2026
  7. [Lilly, Jun 26, 2023] Lilly's phase 2 retatrutide results published in The New England Journal of Medicine show the investigational molecule achieved up to 17.5% mean weight reduction at 24 weeks in adults with obesity and overweight. Eli Lilly and Company press release, PR Newswire copy reposted on BioSpace, Jun 26, 2023. Company press release. Footnote ii states the phase 2 weight figures use the efficacy estimand. Checked Nov 12, 2026
  8. [Lilly, Dec 11, 2025] Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial. Eli Lilly and Company press release, PR Newswire copy, Dec 11, 2025. Company press release. Checked Nov 12, 2026
  9. [Lilly, May 21, 2026] Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial. Eli Lilly and Company press release, PR Newswire copy (investor.lilly.com blocks automated reading), May 21, 2026. Company press release. Checked Nov 12, 2026
  10. [Lancet, Jun 6, 2026] Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. The Lancet (Bajaj HS et al.), Jun 6, 2026. Peer-reviewed paper. Checked Nov 12, 2026
  11. [Lilly, Jul 23, 2026] Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C. Eli Lilly and Company press release, PR Newswire copy, Jul 23, 2026. Company press release. Checked Nov 12, 2026
  12. [NEJM, Sep 29, 2026] Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (TRIUMPH-1). New England Journal of Medicine (Jastreboff AM et al.), print issue Nov 5, 2026, Sep 29, 2026. Peer-reviewed paper. Checked Nov 12, 2026
  13. [Lancet, Sep 29, 2026] Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. The Lancet (Bellido V et al.), Sep 29, 2026. Peer-reviewed paper. Checked Nov 12, 2026
  14. [Lilly, Sep 29, 2026] Lilly's triple agonist, retatrutide, delivered substantial weight loss and A1C reduction, underscoring its potential promise for people with obesity and type 2 diabetes. Eli Lilly and Company press release, PR Newswire, Sep 29, 2026. Company press release. Checked Nov 12, 2026
  15. [7th Cir. brief, Apr 1, 2026] Eli Lilly and Company v. Kennedy, No. 26-1301, Brief of Plaintiff-Appellant (Dkt. 12). U.S. Court of Appeals for the Seventh Circuit, RECAP copy via CourtListener, Apr 1, 2026. Court record (filed by Lilly). Checked Nov 12, 2026
  16. [7th Cir. filing, Oct 8, 2026] Eli Lilly and Company v. Kennedy, No. 26-1301, Supplemental Brief of Appellant (Dkt. 47). U.S. Court of Appeals for the Seventh Circuit, RECAP copy via CourtListener, Oct 8, 2026. Court record (filed by Lilly). We found no decision in the appeal as of Nov 12, 2026; the RECAP copy may not hold every docket entry. Checked Nov 12, 2026
  17. [NEJM, Oct 21, 2026] Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea. New England Journal of Medicine (Grunstein RR et al.), Oct 21, 2026. Peer-reviewed paper. Checked Nov 12, 2026
  18. [Lilly, Oct 28, 2026] Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial. Eli Lilly and Company press release, PR Newswire, Oct 28, 2026. Company press release. Checked Nov 12, 2026
  19. [NEJM, Nov 8, 2026] Retatrutide Once Weekly in Adults with Knee Osteoarthritis Pain and Obesity (TRIUMPH-4 and TRIUMPH-1-OA). New England Journal of Medicine (Schnitzer TJ et al.), online ahead of print, Nov 8, 2026. Peer-reviewed paper. Checked Nov 12, 2026
  20. [ClinicalTrials.gov, Nov 12, 2026] Search results: studies with retatrutide as an intervention (33 records). ClinicalTrials.gov, U.S. National Library of Medicine, Nov 12, 2026. Trial registry. Checked Nov 12, 2026
  21. [ClinicalTrials.gov, NCT06383390] The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity. ClinicalTrials.gov, sponsor Eli Lilly and Company (record updated Oct 8, 2026), Oct 8, 2026. Trial registry record. Checked Nov 12, 2026
  22. [ClinicalTrials.gov, NCT07165028] A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease. ClinicalTrials.gov, sponsor Eli Lilly and Company (record updated Oct 8, 2026), Oct 8, 2026. Trial registry record. Checked Nov 12, 2026
  23. [ClinicalTrials.gov, NCT06662383] A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5). ClinicalTrials.gov, sponsor Eli Lilly and Company (record updated Jul 20, 2026), Jul 20, 2026. Trial registry record. Checked Nov 12, 2026
  24. [ClinicalTrials.gov, NCT07629401] Pre-approval Expanded Access of Retatrutide (LY3437943). ClinicalTrials.gov, sponsor Eli Lilly and Company (record updated Aug 6, 2026), Aug 6, 2026. Trial registry record (expanded access). Checked Nov 12, 2026
  25. [FDA, Oct 1, 2026] FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. U.S. Food and Drug Administration (content current as of Oct 1, 2026), Oct 1, 2026. Regulator. Checked Nov 12, 2026
  26. [FDA, Nov 8, 2023] FDA Approves New Medication for Chronic Weight Management. U.S. Food and Drug Administration, Nov 8, 2023. Regulator. Checked Nov 12, 2026
  27. [Wegovy label, Jun 2026] WEGOVY (semaglutide) injection and tablets, prescribing information. DailyMed, U.S. National Library of Medicine (label version published Jun 30, 2026), Jun 30, 2026. Regulator (drug label). Checked Nov 12, 2026
  28. [FDA, Jun 2021] June 2021 Office of Women's Health e-Update (Wegovy approval for chronic weight management). U.S. Food and Drug Administration, Jun 2021. Regulator. Checked Nov 12, 2026

Changes to this page

  1. Published. Status, trial results and sources checked on this date.