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

Phase 2

Recruiting

• Conditions: Overweight or Obesity
• Interventions: Drug: TERN-601; Other: Matching Placebo

• Registration Number: NCT06854952
• Lead Sponsor: Terns, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Study Start: 2025-03-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TERN-601 Dose 2	TERN-601	Orally administered once daily.
Matching Placebo	Matching Placebo	Orally administered once daily.
TERN-601 Dose 1	TERN-601	Orally administered once daily.
TERN-601 Dose 4	TERN-601	Orally administered once daily.
TERN-601 Dose 3	TERN-601	Orally administered once daily.

Primary Outcome Measures

Name	Time	Method
Percent Change in Body Weight	12 weeks	Percent change (%) in body weight from baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight	12 weeks	Change in body weight (kg) from baseline to Week 12
≥ 5% Weight Loss	12 weeks	Proportion of participants achieving ≥ 5% weight loss

Trial Locations

Locations (1)

FALCON Research Site; 🇺🇸 Arlington, Virginia, United States