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TERN-601 in Adults With Overweight or Obesity
NCT06854952Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2025
- Primary completion
- Aug 2025
- Countries
- 1
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- TERN-601
- Conditions
- obesity
01
Overview
Phase 2, randomised, double-blind trial of TERN-601 in obesity (5 arms), sponsored by Merck & Co. Primary endpoint: Percent Change in Body Weight at 12 weeks. Started Mar 2025; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
TERN-601 250 mg
Orally administered once daily.
TERN-601 500 mg (slow titration)
Orally administered once daily.
TERN-601 500 mg
Orally administered once daily.
TERN-601 750 mg
Orally administered once daily.
Matching Placebo
Orally administered once daily.
03
Who it enrols
Adults aged 18-75 with BMI 30-50 kg/m^2 or 27-30 kg/m^2 with a weight-related comorbidity, HbA1c < 6.5%, and stable body weight. Excludes patients with diabetes mellitus, medication-induced obesity, prior obesity surgery, or history of suicide attempt.
04
Endpoints
Primary
Percent Change in Body Weight
Secondary
Change in Body Weight
Proportion of Participants with >= 5% Weight Loss
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