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Completed

NCT Number: NCT06854952

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

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.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

FALCON Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Female or male aged 18 to 75 years
  • Body mass index (BMI) of:
  • ≥ 30 kg/m^2 to < 50 kg/m^2

OR

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

Key Exclusion Criteria:

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

Treatment and study plan

TERN-601

Drug

Investigational drug

Matching Placebo

Other

Matching placebo

Primary outcomes

  1. Percent Change in Body Weight

    Time frame: 12 weeks

    Percent change (%) in body weight from baseline to Week 12

Secondary outcomes

  1. Change in Body Weight

    Time frame: 12 weeks

    Change in body weight (kg) from baseline to Week 12

  2. ≥ 5% Weight Loss

    Time frame: 12 weeks

    Proportion of participants achieving ≥ 5% weight loss

Sponsors and collaborators

Lead sponsor

Terns, Inc.

Industry

Registry information

Official study title

A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

Acronym: FALCON

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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