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FALCON

CompletedPhase 2

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

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

Lead sponsor

Terns, Inc.

Asset

TERN-601

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

167

actual

Study population

Obesity / overweight

Key I/E criterion

•HbA1c ≤6.5%

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06854952

Org study IDTERN601-2003

Timeline

Milestones

Study first posted2025-03-03actual

Study start2025-03-07actual

Primary completion2025-08-19actual

Study completion2025-09-19actual

Last update posted2025-11-06actual

Assets

Investigational agents

TERN-601

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

3 endpoints

Primary/protocol endpoint

Percent Change in Body Weight

Time frame:12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

≥ 5% Weight Loss

Time frame:12 weeks

≥5% weight-loss responders

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.