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

November 4, 2025 updated by: Terns, Inc.

A Phase 2 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • FALCON Research Site
      • Homewood, Alabama, United States, 35209
        • FALCON Research Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • FALCON Research Site
    • California
      • Spring Valley, California, United States, 91978
        • FALCON Research Site
    • Florida
      • Port Orange, Florida, United States, 32127
        • FALCON Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • FALCON Research Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • FALCON Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • FALCON Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • FALCON Research Site
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • FALCON Research Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • FALCON Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • FALCON Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • FALCON Research Site
      • Houston, Texas, United States, 77079
        • FALCON Research Site
      • San Antonio, Texas, United States, 78229
        • FALCON Research Site
    • Utah
      • St. George, Utah, United States, 84790
        • FALCON Research Site
    • Virginia
      • Arlington, Virginia, United States, 22206
        • FALCON Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TERN-601 Dose 1
Orally administered once daily.
Drug: TERN-601
Investigational drug
Experimental: TERN-601 Dose 2
Orally administered once daily.
Drug: TERN-601
Investigational drug
Experimental: TERN-601 Dose 3
Orally administered once daily.
Drug: TERN-601
Investigational drug
Experimental: TERN-601 Dose 4
Orally administered once daily.
Drug: TERN-601
Investigational drug
Placebo Comparator: Matching Placebo
Orally administered once daily.
Other: Matching Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Body Weight
Time Frame: 12 weeks
Percent change (%) in body weight from baseline to Week 12
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: 12 weeks
Change in body weight (kg) from baseline to Week 12
12 weeks
≥ 5% Weight Loss
Time Frame: 12 weeks
Proportion of participants achieving ≥ 5% weight loss
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terns, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Actual)

August 19, 2025

Study Completion (Actual)

September 19, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERN601-2003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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