GLP-1InvestigationalEvidence tier: Human RCT

Retatrutide

Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.

Quick answer

Retatrutide (Lilly) is an investigational medicine being studied for weight loss. Phase 3 TRIUMPH trials have reported results, and Lilly says it plans to file with the FDA.

FDA status: Investigational, not FDA-approved. Source: NEJM .

In a 48-week phase 2 trial, people on the highest dose lost an average of 24.2% of body weight, compared with 2.1% on placebo.

Last reviewed November 1, 2026 by the PeptideX team. Educational info, not medical advice. PeptideX doesn't give dosing advice. Talk to a licensed clinician.

FDA status

Investigational

Investigational. The FDA has not approved retatrutide for any use. Lilly says it cannot be legally sold or marketed for human use.

Lilly, July 23, 2026

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 180 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

Retatrutide in the literature

Triple agonist targeting GLP-1, GIP, and glucagon receptors for additive metabolic benefits; early trials show superior weight reduction vs dual agonists.

What the literature studies

Triple GLP-1/GIP/Glucagon Agonist

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
3/5

Regulatory record

Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source not verified; no checked date is assigned.

Phase III trials ongoing as of 2025

Retatrutide trial status tracker: StartReta

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Retatrutide is Lilly's investigational triple agonist (GIP/GLP-1/glucagon); phase 3 showed up to 28.3% weight loss vs 2.2% on placebo, Lilly plans to file with FDA in Q1 2027, and it is not approved anywhere.

What it is

A once-weekly injectable peptide that activates GIP, GLP-1 and glucagon receptors [R1].

Legal / FDA status (as of Oct 27 2026)

Investigational; not approved by any regulator. Lilly says it cannot be legally sold or marketed for human use, so online "research" retatrutide is not Lilly product [R3]. Lilly plans a US submission in Q1 2027 [R3][R5]. RE-CHECK after Lilly's Oct 29 2026 Q3 results.

Human evidence

  • Phase 2 (48 wk): -24.2% at 12 mg vs -2.1% placebo [R1].
  • TRIUMPH-1 (80 wk, n~2,339): -28.3% vs -2.2% placebo (efficacy estimand) [R2][R4].
  • TRIUMPH-2 (T2D): -20.8% vs -4.0%; TRIUMPH-3 (BMI>=35 + CVD): -22.6% vs -3.2% [R3].
  • TRIUMPH-4: positive for knee OA pain and weight, Dec 11 2025 [R6].
  • No proven reduction in heart events (TRIUMPH-3 MACE-3 HR 1.12, 95% CI 0.64-1.96) [R3].

Animal / lab evidence

Preclinical work established the triple-agonist design [R1]; the human data now outweigh it.

Risks and unknowns

  • Phase 2: most common adverse events were gastrointestinal, dose-related and mostly mild to moderate; heart rate rose dose-dependently [R1].
  • Gray-market vials: unknown identity, purity, sterility.

What's coming

  • Lilly Q3 results Oct 29 2026; FDA submission planned Q1 2027 [R3]; ongoing phase 3 in CV/renal outcomes, MASLD, back pain [R3].
  • Full timeline: startreta.com/retatrutide-approval (draft).

Sources

  1. [R1] Jastreboff AM et al. Triple-hormone-receptor agonist retatrutide for obesity - a phase 2 trial. NEJM 2023;389:514-526. doi:10.1056/NEJMoa2301972
  2. [R2] Lilly, May 21 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-powerful-weight-loss
  3. [R3] Lilly, Jul 23 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional
  4. [R4] TRIUMPH-1, NEJM 2026. PMID 42814954; NCT05929066
  5. [R5] Lilly, Sep 29 2026 (TRIUMPH-2). https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-substantial-weight
  6. [R6] Lilly, Dec 11 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average

Last checked 2026-10-27

Education only. Not medical advice. No dosing guidance. peptidex.ai does not sell peptides or link to sellers.