Retatrutide Clinical Trials
Current Status & Timeline (2025)
Introduction:
Retatrutide (LY3437943) is a triple-agonist peptide (GLP-1, GIP, glucagon) advancing through a broad Phase 3 TRIUMPH program after Phase 2 studies showed large, dose-dependent weight reduction and favorable metabolic signals.¹⁻³ Ongoing trials span weight management, outcomes (CV/renal), musculoskeletal pain in obesity, and comorbidity subpopulations.⁴⁻¹¹
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Key Trials at a Glance (as of August 16, 2025)
Insert Figure 1: Horizontal timeline of major retatrutide trials (Phase 2 → Phase 3 TRIUMPH program), with estimated primary completion dates.
ALT: “Timeline of retatrutide trials from Phase 2 through ongoing Phase 3 studies.”
Caption: “Figure 1. Retatrutide clinical development milestones and expected readouts.”
| Program / NCT | Phase | Population / Focus | Status* | Duration / Est. Primary Completion |
| TRIUMPH-Outcomes (NCT06383390) | 3 | BMI ≥27 with ASCVD and/or CKD; event-driven CV & kidney outcomes | Recruiting across global sites⁶⁻¹² | ~5 years; Est. primary completion Feb 2029⁹ |
| Maintenance of Weight Reduction (NCT06859268) | 3 | Adults with obesity; weight-loss maintenance after open-label lead-in | Active – Recruiting (last updated Jul 28, 2025)⁴ | 80-wk lead-in + 36-wk RCT; Est. completion Apr 2028⁴ |
| Chronic Low Back Pain in Obesity (NCT07035093) | 3 | Adults with obesity/overweight + chronic low back pain | Active – Recruiting (last updated Jul 11, 2025)⁵ | ~80 weeks; Est. completion Sep 2027⁵ |
| Head-to-Head vs Tirzepatide (NCT06662383; “TRIUMPH-5”) | 3 | Adults with obesity; retatrutide vs tirzepatide | Active – Not Recruiting; ~800 planned; ~89 weeks⁷⁻⁸,¹¹ | Started Nov 2024; primary readout expected after ~89 wks⁷,¹¹ |
| Obesity + OA of Knee (TRIUMPH-4) (NCT05931367) | 3 | Overweight/obesity with knee osteoarthritis | Active – Not Recruiting; ~77 weeks³,¹³ | Started Aug 2023; Est. primary completion Dec 2025¹³ |
| Renal Function in CKD (mixed T2D/no-T2D) (NCT05936151) | 2 | Overweight/obesity with CKD | Active – Not Recruiting (last updated May 5, 2025)¹⁰,¹⁴ | ~31 weeks; kidney endpoints (e.g., measured GFR, UACR)¹⁰,¹⁵ |
*Status reflects site/registry listings most recently updated in July 2025 where available.
Insert Figure 2: World map with pins for active trial geographies (US, Canada, UK, EU, LATAM, etc.), using HP brand colors.
ALT: “Global map of current retatrutide trial sites by study.”
Caption: “Figure 2. Geographic footprint of active Phase 3 retatrutide trials.”
Completed/Published Signals Informing Phase 3
- Phase 2 obesity trial (NEJM 2023): Up to 24% mean weight reduction at 48 weeks; robust lipid and liver fat improvements noted in follow-up reporting.¹,²,¹⁶
- Program expansion: Lilly’s TRIUMPH Phase 3 suite spans weight management, outcomes, and comorbid populations.⁶
What to Watch Next
- First Phase 3 readouts from condition-specific RCTs (e.g., OA knee, back pain) likely before the outcomes trial, given shorter durations.³,⁵,¹³
- Head-to-head efficacy/tolerability vs tirzepatide (NCT06662383) — pivotal for comparative positioning once results mature.⁷⁻⁸,¹¹
CV/renal outcomes (TRIUMPH-Outcomes) — decisive, but on a longer horizon (event-driven; est. primary completion 2029).⁹
FAQs: Retatrutide Trials
Is retatrutide in Phase 3 now?
Yes. Multiple Phase 3 studies across weight management, musculoskeletal pain in obesity, and CV/renal outcomes are underway.⁴⁻⁹
When are results expected?
Shorter RCTs (e.g., OA knee, back pain) have estimated completions 2025–2027, while the CV/renal outcomes trial targets 2029 for primary completion.³⁻⁶,⁹,¹³
How strong were the Phase 2 results?
Phase 2 in adults with obesity showed substantial weight loss (up to ~24% at 48 weeks) with metabolic improvements, supporting Phase 3 progression.¹,²
Are there head-to-head trials?
Yes — a retatrutide vs tirzepatide Phase 3 study is ongoing with ~89-week duration and ~800 participants.⁷⁻⁸,¹¹
Related Articles
- What is Retatrutide
- How Does Retatrutide Work
- Retatrutide Benefits
- Retatrutide Side Effects & Safety
- Semaglutide vs Tirzepatide vs Retatrutide
- What is Semaglutide
- What is Tirzepatide
References
- Jastreboff AM, et al. N Engl J Med. 2023;389(2):145–158. “Triple–Hormone-Receptor Agonist Retatrutide for Obesity.” https://www.nejm.org/doi/full/10.1056/NEJMoa2301972 New England Journal of Medicine
- Lilly press release (Phase 2 publication). https://investor.lilly.com/news-releases/news-release-details/lillys-phase-2-retatrutide-results-published-new-england-journal Lilly Investor Relations
- Abouelmagd AA, et al. Review of early-phase data. Front Endocrinol/PMC (2025). https://pmc.ncbi.nlm.nih.gov/articles/PMC12026077/ PMC