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

Last updated: April 22, 2025
Sponsor: Terns, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Matching Placebo

TERN-601

Clinical Study ID

NCT06854952
TERN601-2003
  • Ages 18-75
  • All Genders

Study Summary

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 Criteria

Inclusion

Key Inclusion Criteria:

  1. Female or male aged 18 to 75 years

  2. Body mass index (BMI) of:

  3. ≥ 30 kg/m^2 to < 50 kg/m^2OR

  4. ≥ 27 kg/m^2 to < 30 kg/m^2 with at least 1 weight-related comorbidity

  5. HbA1c < 6.5%

  6. Stable self-reported body weight for at least 3 months prior to study (< 5% bodyweight gain or loss)

Exclusion

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

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Matching Placebo
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • FALCON Research Site

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • FALCON Research Site

    Homewood, Alabama 35209
    United States

    Active - Recruiting

  • FALCON Research Site

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • FALCON Research Site

    Spring Valley, California 91978
    United States

    Active - Recruiting

  • FALCON Research Site

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • FALCON Research Site

    Louisville, Kentucky 40213
    United States

    Active - Recruiting

  • FALCON Research Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • FALCON Research Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • FALCON Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • FALCON Research Site

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • FALCON Research Site

    St. Peters, Missouri 63303
    United States

    Site Not Available

  • FALCON Research Site

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • FALCON Research Site

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • FALCON Research Site

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • FALCON Research Site

    Houston, Texas 77079
    United States

    Active - Recruiting

  • FALCON Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • FALCON Research Site

    Saint George, Utah 84790
    United States

    Site Not Available

  • FALCON Research Site

    St. George, Utah 84790
    United States

    Site Not Available

  • FALCON Research Site

    Arlington, Virginia 22206
    United States

    Active - Recruiting

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