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A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

CompletedPhase 2

Sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Conditions: Overweight or Obesity

Interventions: TERN-601, Matching Placebo

Countries: United States

This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

1. Female or male aged 18 to 75 years
2. Body mass index (BMI) of:

   1. ≥ 30 kg/m\^2 to \< 50 kg/m\^2

      OR
   2. ≥ 27 kg/m\^2 to \< 30 kg/m\^2 with at least 1 weight-related comorbidity
3. HbA1c \< 6.5%
4. Stable self-reported body weight for at least 3 months prior to study (\< 5% body weight gain or loss)

Key Exclusion Criteria:

1. Have diabetes mellitus
2. Have obesity induced by medication or other diagnosed endocrinologic disorders
3. Have had or are planning surgical treatment or device-based therapy for obesity
4. Lifetime history of suicide attempt

Locations (17)

Birmingham, Alabama, United States
Homewood, Alabama, United States
Tucson, Arizona, United States
Spring Valley, California, United States
Port Orange, Florida, United States
Louisville, Kentucky, United States
Marrero, Louisiana, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
City of Saint Peters, Missouri, United States
Beachwood, Ohio, United States
Medford, Oregon, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
St. George, Utah, United States
Arlington, Virginia, United States