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In clinical trials

Retatrutide

Also called LY3437943, LY-3437943.

Retatrutide is an experimental once-a-week injection from Eli Lilly. It copies three natural gut and body hormones at once (GIP, GLP-1 and glucagon). In large trials, people lost a lot of weight, but it is not approved anywhere yet. Lilly says it plans to ask the US FDA for approval in early 2027.

Retatrutide is not an approved medicine for these uses in most countries. This page explains the science and the law; it does not give dosing, sourcing or usage advice.

How strong is the evidence?

AnecdoteAnimalsHuman trialsApproved
Phase 3. Large trials comparing it with placebo or other drugs.Not approved by any regulator. Evidence comes from Lilly-sponsored trials: phase 1 (single and multiple ascending dose), two published phase 2 trials (obesity, n=338; type 2 diabetes, n=281), a phase 2a liver-fat sub-study, one peer-reviewed phase 3 trial (TRANSCEND-T2D-1, n=537, 40 weeks) and industry topline press releases from the phase 3 TRIUMPH programme (TRIUMPH-4, -1, -2, -3). The TRIUMPH-1, -2, -3 and -4 figures are company-reported topline results that had not been peer-reviewed as of 2026-09-29. No dedicated cardiovascular outcomes result has been reported (in TRIUMPH-3, Lilly reported that major adverse cardiovascular events occurred less often than anticipated in both the retatrutide and placebo arms; the pre-specified hazard ratio for a five-component composite was 0.82, 95% CI 0.55 to 1.22, a range that does not exclude no effect). Lilly plans a US filing in Q1 2027. Preclinical work (mice, rats, hamsters) is used only for mechanism and is labelled animal-only below.

Last verified 2026-09-29 · how we verify

Rendering of PDB 8YW3: Retatrutide bound to the GLP-1 receptor. Experimental structure · cryo-EM 2.68 Å · PDB 8YW3 (2024).
Experimental structure

Experimental structure · cryo-EM 2.68 Å · PDB 8YW3 (2024)RCSB entry ↗

Retatrutide at the GLP-1 receptor. The same study also deposited retatrutide at the GIP receptor (8YW4) and glucagon receptor (8YW5). Fatty diacid side chain not modelled. Nanobody Nb35 (chain N) omitted. Structure from Li et al., Cell Discov 2024. Colours are ours, not the molecule's.

Acts on
GIP receptor, GLP-1 receptor, Glucagon receptor
Taken as
Investigational. In clinical trials it is given by subcutaneous injection once a week. It has no approved route because it is not approved anywhere. Lilly's May 2026 release described it as legally available only to participants in Lilly's clinical trials. Since June 2026 Lilly has also listed a pre-approval, single-patient expanded-access programme, requested by a treating physician, for a narrow group of adults with severe obesity who cannot join a trial.
Half-life
About 6 days (phase 1b study in type 2 diabetes)[src]
Regulatory status
Not approved by any regulator as of 2026-09-29. Lilly says it plans to submit a Biologics License Application to the US FDA in Q1 2027. Lilly describes it as an investigational molecule that cannot be legally sold or marketed for human use.[src]
TRIUMPH-1 (obesity, 80 weeks)
Highest dose: mean weight change -28.3% versus -2.2% with placebo (efficacy estimand); -25.0% versus -3.9% (treatment-regimen estimand). 2,339 randomised adults without diabetes. Company topline result, not yet peer-reviewed.[src]
TRIUMPH-1 extension (104 weeks)
In a pre-specified extension of 532 participants with baseline BMI of 35 or more who completed the main study and tolerated their dose, mean weight change was -30.3% at 104 weeks in the group that continued the highest dose (a selected subgroup).[src]

Inside the body

What Retatrutide does, step by step

Watch the 3D journey →
  1. 01Bloodstream

    One weekly injection that lasts about a week in the blood

    Retatrutide is a small protein-like molecule made in a lab, with a fatty tail attached. In a study in people, half of it was cleared from the blood in about 6 days. That is why it is given once a week.

    For experts

    Retatrutide is a 39-residue peptide with Aib at positions 2 and 20, alpha-methyl-leucine at position 13, and a fatty diacid attached through a linker to Lys17 (Cell Discovery 2024; PubChem structure). In a phase 1b multiple-ascending-dose study in people with type 2 diabetes its pharmacokinetics were dose-proportional with a half-life of about 6 days, supporting once-weekly dosing. The sources cited here do not measure albumin binding or protease resistance for retatrutide, so the contribution of the lipid and of each modified residue to its duration of action is not stated here.[src][src][src]

  2. 02Brain

    It presses three hormone switches at once, and reported hunger drops

    Most weight-loss injections copy one or two hormones. Retatrutide copies three: GIP, GLP-1 and glucagon. It fits into the receptors (docking sites) for each one. In people with type 2 diabetes, it reduced reported hunger and the urge to overeat. Scientists think part of this happens in the brain, but these studies did not look at the brain directly.

    For experts

    Cryo-EM structures of retatrutide bound to GLP-1R, GIPR and GCGR in complex with Gs (PDB 8YW3, 8YW4, 8YW5) show how a single peptide engages all three class B GPCRs. In vitro it shows balanced GCGR and GLP-1R activity and relatively more GIPR activity. In a phase 2 study in adults with type 2 diabetes, pre-specified exploratory questionnaires showed greater reductions in overall appetite, hunger and prospective food consumption than placebo at the higher doses at week 24, and the two highest doses reduced Eating Inventory perceived hunger and disinhibition; these reductions correlated modestly with weight loss at week 36 (r about 0.3). Central mechanisms are inferred from incretin receptor biology; these questionnaires are patient-reported and exploratory, and the studies did not directly image brain circuits.[src][src][src]

  3. 03Stomach

    Food leaves the stomach more slowly

    A Lilly study reported that retatrutide slows how fast the stomach empties, as other drugs in this family do. This may help people feel full for longer, and may be one reason nausea is common.

    For experts

    A short Lilly report (Diabetes Obes Metab 2023) is titled as showing that retatrutide delays gastric emptying; its abstract was not available to check, so the species studied, size and time course of the delay are not summarised here. Delayed gastric emptying is a recognised effect of GLP-1 receptor agonists and is thought to contribute to satiety and to the gastrointestinal adverse events (nausea, vomiting, diarrhoea, constipation) reported in the phase 2 and phase 3 trials.[src][src][src]

  4. 04Pancreas

    Blood sugar is lowered in people with type 2 diabetes

    GIP and GLP-1 tell the pancreas to release insulin when blood sugar is high. In trials in people with type 2 diabetes, retatrutide lowered blood sugar a lot, and in one trial more than the diabetes drug dulaglutide.

    For experts

    In the 24-week phase 2 trial in type 2 diabetes, HbA1c fell by up to about 2.0 percentage points (placebo-unadjusted least-squares mean change), with two of the higher-dose groups giving significantly greater HbA1c reductions than dulaglutide, and there were no reports of severe hypoglycaemia. In the phase 3 TRANSCEND-T2D-1 monotherapy trial, treatment-regimen HbA1c changes were -1.69% to -1.94% versus -0.81% with placebo at 40 weeks. The trials measured glycaemia, not insulin secretion directly in these reports; attributing the effect to glucose-dependent GIP and GLP-1 signalling on beta cells is an inference from receptor pharmacology.[src][src][src]

  5. 05Fat tissue

    Body fat falls; the glucagon part may also raise energy use

    In people with type 2 diabetes, body fat fell a lot. The share of weight lost as lean tissue (such as muscle) was similar to other obesity medicines. The glucagon part is meant to make the body burn more energy. That extra burning was shown in mice; it has not been proven in humans.

    For experts

    In a DXA sub-study of the phase 2 type 2 diabetes trial, total fat mass fell by up to 26.1% (pooled second-highest dose group) versus 4.5% with placebo at 36 weeks, and the authors reported that the proportion of lean mass loss relative to weight loss was similar to other obesity treatments. The mouse work (animal-only evidence) attributed part of the weight loss to GCGR-mediated increases in energy expenditure on top of GIPR- and GLP-1R-driven reduction in food intake. A human energy-expenditure effect is not demonstrated in the studies cited here.[src][src]

  6. 06Liver

    Fat in the liver drops sharply

    Many people with obesity have extra fat stored in their liver. In a smaller trial, retatrutide cut liver fat a great deal, and most people at the higher doses ended up with a normal amount. Larger studies are needed to know what this means for long-term liver health.

    For experts

    In the phase 2a MASLD sub-study (n=98, participants with at least 10% baseline liver fat), the mean relative change in liver fat at 24 weeks was +0.3% with placebo versus -42.9%, -57.0%, -81.4% and -82.4% across increasing retatrutide doses; normal liver fat (below 5%) was reached by 0% with placebo and 27%, 52%, 79% and 86% respectively. Reductions were significantly related to weight loss, abdominal fat and insulin-sensitivity measures. Glucagon receptor signalling in hepatocytes is a plausible contributor but this sub-study did not separate direct from weight-mediated effects. The published results report liver fat, not liver biopsy (histology) outcomes.[src]

  7. 07Kidneys

    Early kidney signals, still being tested

    In early analyses, retatrutide lowered a protein leak in urine that can signal kidney strain. A small kidney trial is studying how it affects kidney function, and a larger heart-and-kidney outcomes trial is under way. Whether it protects kidneys over time is not yet known.

    For experts

    A post hoc analysis of the two phase 2 trials (eGFR at least 45) found that, versus placebo, the highest dose reduced urine albumin-to-creatinine ratio by 37.0% (95% CI -57.3 to -7.0) at 36 weeks in type 2 diabetes, and the two higher doses reduced it by 28.0% and 31.5% at 48 weeks in obesity without diabetes, with creatinine-based eGFR increases of 5.3 and 8.5 mL/min/1.73 m2 in the obesity study but not in the diabetes study. Most participants had normal albuminuria, so absolute changes were modest. These are post hoc and hypothesis-generating. TRANSCEND-CKD, a phase 2b mechanistic trial (n=146 randomised; primary endpoint measured GFR by iohexol clearance at 24 weeks), has published its design; that paper names TRIUMPH-Outcomes (NCT06383390) as the ongoing cardio-kidney outcome trial. No results from either are cited here.[src][src]

  8. 08Heart

    Heart-risk markers improve, but heart rate goes up and outcomes are unproven

    Blood pressure, blood fats and a marker of inflammation improved. Heart rate went up, peaking at around 24 weeks and then easing. It is not yet known whether retatrutide reduces heart attacks or strokes.

    For experts

    Phase 2 post hoc analyses reported reductions in non-HDL cholesterol, apolipoprotein B, triglyceride-rich lipoproteins and (in the obesity trial) hs-CRP and IL-6. The phase 2 obesity trial reported dose-dependent heart-rate increases that peaked at 24 weeks and declined thereafter. In TRIUMPH-3 (severe obesity with established cardiovascular disease), Lilly reported that MACE occurred less frequently than anticipated in both the retatrutide and placebo arms; the pre-specified in-study hazard ratios (pooled doses versus placebo) were 0.82 (95% CI 0.55 to 1.22) for MACE-5 and 1.12 (0.64 to 1.96) for MACE-3. Both intervals include no effect, so these topline data neither show nor exclude a cardiovascular benefit.[src][src][src]

For experts

The detail

Retatrutide (LY3437943) is an investigational, once-weekly, subcutaneously administered single-peptide agonist of the GIP, GLP-1 and glucagon receptors (GIPR, GLP-1R, GCGR). It is a 39-residue synthetic peptide (about 4.73 kDa) with three non-proteinogenic residues (Aib at positions 2 and 20, alpha-methyl-leucine at position 13), a C-terminal amide, and a C20 fatty diacid attached to Lys17 through a linker. In vitro it shows balanced GCGR and GLP-1R activity with relatively more GIPR activity (Coskun 2022). In a phase 1b multiple-ascending-dose study in type 2 diabetes, exposure was dose-proportional and the half-life was about 6 days, supporting weekly dosing. Phase 2 trials in obesity (NEJM 2023, NCT04881760) and type 2 diabetes (Lancet 2023, NCT04867785) showed dose-dependent weight and HbA1c reductions; the obesity trial reported a 24.2% mean weight reduction at 48 weeks in the highest-dose group versus 2.1% with placebo. The phase 3 TRIUMPH programme reported topline results in TRIUMPH-4 (knee osteoarthritis, December 2025), TRIUMPH-1 (obesity, May 2026, 2,339 participants, up to 28.3% mean weight loss at 80 weeks on the efficacy estimand versus 2.2% with placebo) and TRIUMPH-2 and TRIUMPH-3 (July 2026). TRANSCEND-T2D-1, a 40-week phase 3 monotherapy trial in type 2 diabetes, has been peer-reviewed (Lancet 2026). Common adverse events are gastrointestinal (nausea, diarrhoea, constipation, vomiting); dysesthesia has emerged as a notable dose-related signal in phase 3. Retatrutide is not approved by any regulator. Lilly says it plans a US Biologics License Application in Q1 2027; whether FDA treats it as a biologic (BLA) or a drug (NDA) has been disputed in court because of how amino acids in the molecule are counted. Outside clinical trials and a limited expanded-access programme it has no lawful supply, and products sold online as retatrutide are unapproved.

Evidence: Not approved by any regulator. Evidence comes from Lilly-sponsored trials: phase 1 (single and multiple ascending dose), two published phase 2 trials (obesity, n=338; type 2 diabetes, n=281), a phase 2a liver-fat sub-study, one peer-reviewed phase 3 trial (TRANSCEND-T2D-1, n=537, 40 weeks) and industry topline press releases from the phase 3 TRIUMPH programme (TRIUMPH-4, -1, -2, -3). The TRIUMPH-1, -2, -3 and -4 figures are company-reported topline results that had not been peer-reviewed as of 2026-09-29. No dedicated cardiovascular outcomes result has been reported (in TRIUMPH-3, Lilly reported that major adverse cardiovascular events occurred less often than anticipated in both the retatrutide and placebo arms; the pre-specified hazard ratio for a five-component composite was 0.82, 95% CI 0.55 to 1.22, a range that does not exclude no effect). Lilly plans a US filing in Q1 2027. Preclinical work (mice, rats, hamsters) is used only for mechanism and is labelled animal-only below.[src][src][src][src][src][src][src][src][src]

Known safety signals

  • In TRIUMPH-1 the most common adverse events were gastrointestinal. At the highest dose versus placebo: nausea 42.4% vs 14.8%, diarrhoea 32.0% vs 13.5%, vomiting 25.3% vs 4.8%, constipation 26.1% vs 10.9%. Dysesthesia (abnormal skin sensations such as tingling or altered touch) was reported in 12.5% vs 0.9%, and urinary tract infections in 8.4% vs 5.3%. Discontinuation due to adverse events was 11.3% at the highest dose versus 4.9% with placebo. Retatrutide has no approved label, so there is no boxed warning or official safety statement yet.[src]
  • In TRIUMPH-4 (knee osteoarthritis), dysesthesia (abnormal skin sensations such as tingling or altered touch) was reported in 8.8% and 20.9% of people on the two retatrutide doses versus 0.7% with placebo. Lilly described these events as generally mild and said they rarely led to stopping treatment. In TRIUMPH-4 (knee osteoarthritis), discontinuation due to adverse events was 18.2% at the highest dose versus 4.0% with placebo; Lilly said these rates correlated with baseline BMI and included stopping for perceived excessive weight loss.[src]
  • The phase 2 obesity trial reported dose-dependent increases in heart rate that peaked at 24 weeks and declined thereafter, and gastrointestinal events that were dose-related and mostly mild to moderate.[src]
  • In a warning letter dated 2026-03-31 to a firm whose products included retatrutide, FDA stated that the products were unapproved new drugs. It said that, despite 'Research Use Only' and 'not intended for human consumption' labelling, evidence from the firm's website showed the products were intended as drugs, and noted that injectable products bypass some of the body's key defences against toxins and microorganisms.[src]
  • Australia's TGA warns that many peptide products supplied in Australia are unapproved, have not been assessed by the TGA for safety, quality or effectiveness, may not meet required standards and may be incorrectly labelled. This release is about unapproved peptides in general and does not name retatrutide.[src]
  • A 2026 case report described a man with type 1 diabetes who developed ketosis and acute kidney injury after using an online-purchased product marketed as retatrutide. The author states that causation cannot be established: stool culture also grew Shigella, and he had omitted insulin while unwell.[src]

Around the world

Is Retatrutide legal where you live?

CountryStatusWhat it meansVerified
AustraliaProhibitedNot approved by the TGA or any comparable regulator. The TGA names retatrutide in peptide warnings and seizures, and a product sold as retatrutide contained semaglutide instead.Details →source2026-09-29
BrazilProhibitedNot approved anywhere; Anvisa says products sold as retatrutide are illegal and has seized themDetails →source2026-09-29
CanadaProhibitedNot authorised; Health Canada named retatrutide among unauthorised injectable drugs it has seized (April 2026)Details →source2026-09-29
ChinaNot approvedNot approved in China or anywhere else; only trial-stage filings exist.Details →source2026-09-29
European UnionNot approvedInvestigational; no EU marketing authorisation and no application under evaluationDetails →source2026-09-29
IndiaNot approvedNot approved in India; retatrutide is only in CDSCO-permitted Phase III trials run by Eli LillyDetails →source2026-09-29
JapanNot approvedNo marketing approval in Japan; the investigational triple agonist retatrutide does not appear in PMDA's approved-drug lists to September 2026Details →source2026-09-29
MexicoNot approvedNot registered in Mexico; retatrutide is unapproved everywhereDetails →source2026-09-29
New ZealandProhibitedNot approved; Medsafe says retatrutide sold to the public is black-market and is being seizedDetails →source2026-09-29
United Arab EmiratesProhibitedNot approved; the EDE named retatrutide in July 2026 when it acted against 71 sources marketing or selling unapproved peptide productsDetails →source2026-09-29
United KingdomProhibitedNot authorised in the UK; the MHRA says selling it is illegal and has raided sites making and supplying itDetails →source2026-09-29
United StatesProhibitedNot approved; FDA says retatrutide cannot be compounded and has warned sellers, so lawful access is limited to trials and expanded accessDetails →source2026-09-29

Who makes it

Recent history

  1. 2026-08-12

    Lilly files six lawsuits over unapproved retatrutide products

  2. 2026-07-23

    Lilly reports two more phase 3 retatrutide trials, with up to about 21% to 23% weight loss at 80 weeks

  3. 2026-05-29

    UK regulator reports its largest seizure of unlicensed weight loss medicines

  4. 2026-05-21

    Lilly reports phase 3 TRIUMPH-1 results for retatrutide: up to about 28% weight loss at 80 weeks

  5. 2026-03-31

    US Customs reports about 5,000 mis-manifested peptide shipments seized in Cincinnati

  6. 2026-03-31

    FDA warning letter says 'research use only' labels do not change intended human use of peptide products

  7. 2023-06-26

    Retatrutide phase 2 trial: up to about 24% weight loss at 48 weeks

Full timeline →

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Sources (74)

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  2. 02Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USAThe Lancet (PubMed) · 2023-08-12 · accessed 2026-09-29
  3. 03Efficacy 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 trialThe Lancet (PubMed) · 2026-06-13 · accessed 2026-09-29
  4. 04Lilly's triple agonist, retatrutide, delivered powerful weight loss in pivotal Phase 3 obesity trial (TRIUMPH-1 topline)Eli Lilly and Company (PR Newswire) · 2026-05-21 · accessed 2026-09-29
  5. 05Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials (TRIUMPH-2 and TRIUMPH-3 topline)Eli Lilly and Company (PR Newswire) · 2026-07-23 · accessed 2026-09-29
  6. 06Lilly'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 (TRIUMPH-4 topline)Eli Lilly and Company (PR Newswire) · 2025-12-11 · accessed 2026-09-29
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