Is Retatrutide FDA Approved? Phase 3 Results and Status, October 2026

Retatrutide is still investigational in October 2026. What the published phase 3 trials (TRIUMPH-2, TRANSCEND-T2D-1) and the phase 2 obesity trial found, including side effects.

Quick answer

No. As of October 9, 2026, retatrutide is an investigational drug from Eli Lilly with no FDA approval. Published phase 3 trials report average weight loss of up to 18.8% at 80 weeks in adults with obesity and type 2 diabetes (versus 5.1% with placebo), with more stomach side effects than placebo.

The Short Answer

No. As of October 9, 2026, retatrutide has no FDA approval; it remains under investigation by Eli Lilly for obesity, type 2 diabetes, knee osteoarthritis and obstructive sleep apnea (TRIUMPH design paper). We found no retatrutide entry in FDA’s approved-drug data.

It works on three hormone receptors (GIP, GLP-1 and glucagon). Two phase 3 trials have been published, both in people with type 2 diabetes. Evidence: A for weight and blood-sugar change in trials; long-term safety is not yet known.

What the Trials Found

What the Trials Found
TrialWhoLengthWeight changePlacebo
Phase 2 obesity (NEJM 2023)338 adults with obesity48 weeks−8.7% (1 mg) to −24.2% (12 mg)−2.1%
TRIUMPH-2 (Lancet 2026)1,152 adults with obesity and type 2 diabetes80 weeks−11.9% (4 mg), −16.8% (9 mg), −18.8% (12 mg)−5.1%
TRANSCEND-T2D-1 (Lancet 2026)537 adults with type 2 diabetes on diet and exercise40 weeks−11.5% (4 mg) to −15.3% (12 mg); HbA1c −1.69% to −1.94%−2.6%; HbA1c −0.81%

Sources: Jastreboff 2023, TRIUMPH-2, TRANSCEND-T2D-1. For how this compares with approved drugs, see retatrutide vs tirzepatide.

Side Effects Reported So Far

In TRIUMPH-2, diarrhea affected 27–34% of people on retatrutide versus 13% on placebo, and nausea 14–28% versus 8%. Low blood pressure and dysesthesia (abnormal skin sensations) were more common with retatrutide, and stopping treatment because of adverse events or death was more frequent at 9 mg (12%) and 12 mg (8%) than with placebo (5%) (TRIUMPH-2).

The phase 2 trial reported dose-related stomach side effects and heart-rate increases that peaked at 24 weeks (Jastreboff 2023). More on the drug: retatrutide reference page. Approved drugs in the same family include tirzepatide and semaglutide.

Questions

Common questions

4 answers
Is retatrutide FDA approved?

No. As of October 9, 2026 it is an investigational drug with no FDA approval.

How much weight did people lose on retatrutide?

In TRIUMPH-2, adults with obesity and type 2 diabetes lost 11.9% to 18.8% of body weight at 80 weeks depending on the dose, versus 5.1% with placebo. In the phase 2 obesity trial, the 12 mg group lost 24.2% at 48 weeks.

What are retatrutide’s side effects?

Mostly stomach effects such as diarrhea and nausea. TRIUMPH-2 also reported more low blood pressure and dysesthesia than placebo, and the phase 2 trial reported heart-rate increases that peaked at 24 weeks.

Is retatrutide sold online the same drug?

Not necessarily. Products sold online are not FDA-approved and are not the drug supplied in Lilly’s trials, so their identity and purity are unknown.

Medical Disclaimer: This is general education, not medical advice. Researched and written by Kymata Health Editorial; sources cited inline. Retatrutide is an investigational drug. Doses are described only as what a trial gave. Products sold online as retatrutide are not the drug tested in these trials. Evidence grades: A = several randomized trials or a meta-analysis; B = at least one randomized trial; C = small or pilot human data, expert consensus, or mechanism only; D = animal or cell data, or anecdote.

References

Sources cited in this article

4 sources
  1. 1Triple-hormone-receptor agonist retatrutide for obesity: a phase 2 trialJastreboff AM, et al., N Engl J Med 2023 · PMID: 37366315
  2. 2Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trialBellido V, et al., Lancet 2026 · PMID: 42810372
  3. 3Efficacy and safety of retatrutide in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trialBajaj HS, et al., Lancet 2026 · PMID: 42250575
  4. 4Retatrutide for the treatment of obesity, obstructive sleep apnea and knee osteoarthritis: rationale and design of the TRIUMPH registrational clinical trialsGiblin K, et al., Diabetes Obes Metab 2026 · PMID: 41090431

Educational only. Not medical advice. Some links earn us a commission: kymatahealth.com/affiliate-disclosure.