Library / Weight and metabolic

Retatrutide

Also known as LY3437943

Human trials

Investigational triple agonist peptide acting on GIP, GLP-1 and glucagon receptors, studied for obesity, type 2 diabetes and related conditions. Phase 2 and phase 3 results have been published but it is not approved anywhere.

Not an approved medicine. Retatrutide is not an approved medicine for this use in Australia or the United States. This page summarises published research for information only. It is not a recommendation to use Retatrutide, and VialOwl does not sell or supply it.

Background

Retatrutide (LY3437943) is an investigational once weekly injectable peptide developed by Eli Lilly. Phase 2 results were published in 2023 and phase 3 TRIUMPH and TRANSCEND trials reported from 2026. It is not approved anywhere.

How it is thought to work

It activates three hormone receptors at once: GLP-1 and GIP, which reduce appetite and improve insulin release, and glucagon, which is thought to increase energy use and liver fat burning.

What is claimed, and the evidence

ClaimEvidenceNotes
Weight loss in adults with obesityHuman trialsPhase 2: up to 24 per cent at 48 weeks. Phase 3 TRIUMPH-1 (company topline, May 2026): 17.6 to 25.0 per cent at 80 weeks versus 3.9 per cent with placebo (treatment regimen estimand).
Blood sugar control in type 2 diabetesHuman trialsPhase 3 TRANSCEND-T2D-1 (537 people): HbA1c fell 1.7 to 1.9 percentage points versus 0.8 with placebo over 40 weeks.
Reduced liver fatHuman trialsPhase 2a randomised trial in fatty liver disease.
Muscle preserving or 'better than tirzepatide' for everyoneNo published evidenceOnline claims; no head to head trial results published.

Side effects

EffectHow oftenNotes
NauseaCommon29 to 42 per cent versus 15 per cent with placebo in TRIUMPH-1, rising with dose.
DiarrhoeaCommon25 to 34 per cent versus 14 per cent with placebo in TRIUMPH-1.
ConstipationCommon24 to 26 per cent versus 11 per cent with placebo in TRIUMPH-1.
VomitingCommon11 to 25 per cent versus 5 per cent with placebo in TRIUMPH-1.
Dysaesthesia (abnormal skin sensations such as tingling or burning)Common5 to 12.5 per cent versus 0.9 per cent with placebo in TRIUMPH-1; mostly mild to moderate. A new signal not typical of the class.
Urinary tract infectionCommon7.5 to 8.8 per cent versus 5.3 per cent with placebo in TRIUMPH-1.
Increased heart rateCommonDose dependent rises peaking at 24 weeks in the phase 2 trial.
Stopping treatment because of side effectsCommon4.1 to 11.3 per cent versus 4.9 per cent with placebo in TRIUMPH-1.
Severe vomiting with oesophageal tear from a counterfeit product
Serious
Case reportsTGA investigated a hospitalised case; the vial contained about 8 times the approved semaglutide level and no retatrutide.

Warnings

  • Not approved by the TGA or any comparable regulator; the TGA says any retatrutide outside a clinical trial could be counterfeit.
  • TGA testing in September 2026 found a product sold as retatrutide contained undeclared high dose semaglutide and no retatrutide, after a consumer was hospitalised.
  • Full phase 3 safety data are not yet published; dysaesthesia is an emerging signal.
  • Unapproved products are not assessed by the TGA for quality, safety or efficacy and may be contaminated, non-sterile, underdosed, overdosed or contain a different substance altogether.

Phase 3 trials

TRANSCEND-T2D-1

Phase 3, Completed, published. 537 participants, 40 weeks. NCT06354660

Population
Adults with type 2 diabetes managed with diet and exercise alone, HbA1c 7.0 to 9.5%.
Arms
Retatrutide 4 mg weekly; Retatrutide 9 mg weekly; Retatrutide 12 mg weekly; Placebo
Primary outcome
Change in HbA1c.
Results
HbA1c fell 0.88, 1.04 and 1.12 percentage points more than placebo. Body weight changed by minus 11.5%, 13.9% and 15.3% against minus 2.6% on placebo.
Safety
Stopped because of adverse events: 2 to 5% on retatrutide against 0% on placebo.
Source
Bajaj HS et al. Lancet 2026;407:2402-13.

TRIUMPH-1

Phase 3, Completed, not yet published. 2,335 participants, 80 weeks. NCT05929066

Population
Adults with BMI of 30 or more, or 27 or more with a related condition, without diabetes.
Arms
Retatrutide 4 mg weekly; Retatrutide 9 mg weekly; Retatrutide 12 mg weekly; Placebo
Primary outcome
Percentage change in body weight at week 80.
Results
Body weight changed by minus 17.6%, 23.7% and 25.0% against minus 3.9% on placebo (treatment-regimen estimand, counting everyone randomised).
Safety
Nausea 28.6%, 38.4% and 42.4% against 14.8%. Dysaesthesia 5.1%, 12.3% and 12.5% against 0.9%. Stopped because of adverse events: 4.1%, 6.9% and 11.3% against 4.9%.
Source
Eli Lilly press release, 21 May 2026. Company announcement, not peer reviewed.

TRIUMPH-4

Phase 3, Completed, not yet published. 445 participants, 68 weeks, starting at 2 mg and stepping up every 4 weeks. NCT05931367

Population
Adults with BMI of 27 or more and knee osteoarthritis.
Arms
Retatrutide 9 mg weekly; Retatrutide 12 mg weekly; Placebo
Primary outcome
WOMAC knee pain score and percentage change in body weight at week 68.
Results
Body weight changed by minus 20.0% and 23.7% against minus 4.6% on placebo (treatment-regimen estimand, counting everyone randomised). WOMAC pain fell 4.5 and 4.4 points against 2.4.
Safety
Nausea 38.1% and 43.2% against 10.7%. Dysaesthesia 8.8% and 20.9% against 0.7%. Stopped because of adverse events: 12.2% and 18.2% against 4.0%.
Source
Eli Lilly press release, 11 December 2025. Company announcement, not peer reviewed.

Doses in these trials were given under medical supervision.

Regulatory status

Australia
Not approved and not on the ARTG. TGA states it is undergoing clinical trials and has not been approved by the TGA or any comparable regulator; in September 2026 TGA testing found a product sold as retatrutide contained undeclared semaglutide and no retatrutide.
United States
Not FDA approved; investigational (phase 3 TRIUMPH programme). FDA states it cannot be used in compounding. Sponsor has indicated a planned submission in 2027 (Not verified with FDA).

Sources

  1. PubMed: Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial
  2. PubMed: Efficacy and safety of retatrutide in type 2 diabetes (TRANSCEND-T2D-1)
  3. Eli Lilly via PR Newswire: Retatrutide TRIUMPH-1 phase 3 topline results (21 May 2026)
  4. TGA: TGA tests counterfeit retatrutide product following serious adverse event report (14 September 2026)

Also in Weight and metabolic

From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Retatrutide.