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

NCT ID: NCT06854952

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-07

Study Completion Date

2025-09-19

Brief Summary

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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

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Conditions

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Overweight or Obesity

Keywords

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overweight obesity obese glucagon-like peptide-1 receptor agonist GLP-1 receptor agonist GLP-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TERN-601 Dose 1

Orally administered once daily.

Group Type EXPERIMENTAL

TERN-601

Intervention Type DRUG

Investigational drug

TERN-601 Dose 2

Orally administered once daily.

Group Type EXPERIMENTAL

TERN-601

Intervention Type DRUG

Investigational drug

TERN-601 Dose 3

Orally administered once daily.

Group Type EXPERIMENTAL

TERN-601

Intervention Type DRUG

Investigational drug

TERN-601 Dose 4

Orally administered once daily.

Group Type EXPERIMENTAL

TERN-601

Intervention Type DRUG

Investigational drug

Matching Placebo

Orally administered once daily.

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Matching placebo

Interventions

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TERN-601

Investigational drug

Intervention Type DRUG

Matching Placebo

Matching placebo

Intervention Type OTHER

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Terns, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FALCON Research Site

Birmingham, Alabama, United States

Site Status

FALCON Research Site

Homewood, Alabama, United States

Site Status

FALCON Research Site

Tucson, Arizona, United States

Site Status

FALCON Research Site

Spring Valley, California, United States

Site Status

FALCON Research Site

Port Orange, Florida, United States

Site Status

FALCON Research Site

Louisville, Kentucky, United States

Site Status

FALCON Research Site

Marrero, Louisiana, United States

Site Status

FALCON Research Site

Boston, Massachusetts, United States

Site Status

FALCON Research Site

Rochester, Minnesota, United States

Site Status

FALCON Research Site

City of Saint Peters, Missouri, United States

Site Status

FALCON Research Site

Beachwood, Ohio, United States

Site Status

FALCON Research Site

Medford, Oregon, United States

Site Status

FALCON Research Site

Dallas, Texas, United States

Site Status

FALCON Research Site

Houston, Texas, United States

Site Status

FALCON Research Site

San Antonio, Texas, United States

Site Status

FALCON Research Site

St. George, Utah, United States

Site Status

FALCON Research Site

Arlington, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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TERN601-2003

Identifier Type: -

Identifier Source: org_study_id