Clinical Trials Tracker

What's published, what's pending, and when approval is expected.

A living tracker of every retatrutide clinical trial from Phase 1 through the TRIUMPH Phase 3 program, plus the FDA approval timeline. Updated as new readouts are published.

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The program at a glance

PhaseTrialNDurationStatusHeadline
1NCT04143802 (T2D)12 wksComplete-8.5 kg; -0.9% HbA1c
2NCT04881760 (obesity)33848 wksComplete-24.2% at 12 mg
2NCT04867785 (T2D)28136 wksComplete-2.02% HbA1c, -16.94% weight
2MASLD sub-studyComplete81–86% liver fat reduction
3TRIUMPH-1 (obesity)2,33980 wksCompletePivotal. -28.3% at 12 mg; reported May 2026.
3TRIUMPH-2 (obesity + T2D)ActiveReadout expected 2026
3TRIUMPH-3 (CV disease)1,94680 wksActive, not recruitingNo results posted
3TRIUMPH-4 (knee OA)44568 wksComplete-28.7%; 74–76% pain reduction
3TRIUMPH-5 (vs tirzepatide)~800Active, not recruitingHead-to-head body-weight primary
3bTRIUMPH-6 (maintenance)643ActiveClosed to new enrollment
3TRIUMPH-Outcomes (CV / renal)~10,000Multi-yearActive, not recruitingCV composite (incl. HF) + kidney

Total TRIUMPH Phase 3 enrollment: approximately 5,800 participants. See the full clinical trials deep dive for each trial's design, endpoints, and citations.

2026 readout calendar

  • Reported. TRIUMPH-4 (Dec 2025), TRANSCEND-T2D-1 (Mar 2026), and the pivotal TRIUMPH-1 (May 21, 2026) have all read out.
  • Still expected in 2026. TRIUMPH-2 (obesity + T2D) and TRIUMPH-3 (CV disease) results remain outstanding; TRIUMPH-3 has completed primary data collection.
  • 2027+. TRIUMPH-5 (head-to-head vs tirzepatide, NCT06662383) and TRIUMPH-Outcomes (CV/kidney CVOT, NCT06383390) are multi-year; earliest reads from 2027+.

How to participate

TRIUMPH-5 (head-to-head vs tirzepatide) and TRIUMPH-Outcomes (CV/kidney endpoints, ~10,000 participants) are both active, not recruiting — closed to new participants. Two studies are still open: TRIUMPH-7 (NCT07035093), for obesity or overweight with chronic low back pain, and the Phase 3 multi-agent MASLD master protocol (NCT07165028), which studies several drugs rather than retatrutide alone. Always re-check status before applying:

FDA timeline

The FDA filing trigger was the TRIUMPH-1 primary readout, which reported in May 2026. Retatrutide remains investigational; no BLA submission or FDA decision date has been confirmed by Lilly or the FDA. See the FDA approval timeline article for the full scenario analysis.