What does the retatrutide research show?
Retatrutide now has pivotal Phase 3 human efficacy data in addition to its Phase 2 obesity and MASLD trials, though it remains investigational and is not approved in any jurisdiction. The research-grade material supplied for laboratory use is unapproved laboratory material, not the finished pharmaceutical studied in these trials.
Retatrutide evidence at a glance
The trial programme so far
The randomised Phase 2 obesity trial (N Engl J Med, 2023; PMID 37385275) reported a mean change from baseline in body weight of −24.2% at week 48 in the 12 mg arm, with more than 90% of that arm reaching a ≥10% reduction. A Phase 2a MASLD trial (Nat Med, 2024) measured liver-fat fraction by MRI-PDFF and reported relative reductions of up to 82.4% at the protocol-defined timepoint.
The Phase 3 TRIUMPH-1 trial (NCT05929066, 2025) reported a mean change from baseline in body weight of −28.3% at week 80 in the 12 mg arm, with 45.3% of that arm reaching ≥30%, and up to −30.3% at week 104 in a higher-BMI extension cohort. Type 2 diabetes studies recorded HbA1c reductions of 1.3-2.0% as a protocol-defined endpoint. Every figure belongs to the study, arm and timepoint that produced it.
Frequently asked questions
Is retatrutide FDA approved?
No. Retatrutide is still in clinical trials and is not approved by the FDA, EMA, or any other regulator. Retatrutide is an unapproved, research-grade lyophilised powder.
What adverse events were reported in the published clinical research?
Investigators reported predominantly gastrointestinal events — nausea, diarrhoea, vomiting, constipation — described as scaling with arm level and during the protocol-defined step-up period, plus transient heart-rate increases and transient glucose elevation attributed to the GCGR arm. Discontinuation due to adverse events in TRIUMPH-1 was reported at 4.1% (4 mg), 6.9% (9 mg) and 11.3% (12 mg) against 4.9% on placebo. Those observations describe those study populations under those protocols. Retatrutide remains investigational and no human safety profile is established outside controlled clinical trials.
Certificates of Analysis for released batches are published on the website. Browse the lab-verified catalogue — research use only.
References
Related research
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