Oral GLP ‐ 1RA TERN ‐601 for Adults With Obesity/Overweight: Placebo‐Controlled, Multiple‐Ascending‐Dose, Phase 1 and 2 Studies
Authors' conclusion
TERN-601 demonstrated modest, dose-dependent weight loss with a gastrointestinal tolerability profile consistent with GLP-1 receptor agonists. However, liver safety findings observed in the Phase 2 study led to clinical development discontinuation.
Study context
- Population
- Adults with obesity or overweight
- Comparison
- TERN-601 vs placebo
Methodological detailsPhase 1 and Phase 2, double-blind, placebo-controlled, multiple-ascending-dose
- Phase 1 and Phase 2
- Double-blind
- Placebo-controlled
- Multiple-ascending-dose
Primary result
As reported in the abstract
Weight change · 28 days (Phase 1); Week 12 (Phase 2)
- Phase 1: dose-dependent weight loss over 28 days, statistically significant reductions vs placebo at all doses
- Phase 2: doses ≥ 500 mg gave significantly greater mean percentage weight loss at Week 12 vs placebo
Further findings
Pharmacodynamic effects (Phase 1)
- GLP-1-consistent pharmacodynamic effects, incl. reduced appetite and delayed gastric emptying
Safety
Gastrointestinal treatment-emergent adverse events
- GI adverse events consistent with the GLP-1 RA class and dose-related
Transaminase elevations consistent with potential drug-induced liver injury (Phase 2)
- Participants with transaminase elevations consistent with potential drug-induced liver injury
- 3
- Led to clinical development discontinuation
Original publication
Oral GLP ‐ 1RA TERN ‐601 for Adults With Obesity/Overweight: Placebo‐Controlled, Multiple‐Ascending‐Dose, Phase 1 and 2 Studies. Obesity (Silver Spring). Published 30 July 2026. doi:10.
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