NCT06854952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

February 25, 2025

Last Update Submit

November 4, 2025

Conditions

Overweight or Obesity

Keywords

overweightobesityobeseglucagon-like peptide-1 receptor agonistGLP-1 receptor agonistGLP-1

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Body Weight

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

    12 weeks

Secondary Outcomes (2)

  • Change in Body Weight

    12 weeks

  • ≥ 5% Weight Loss

    12 weeks

Study Arms (5)

TERN-601 Dose 1

EXPERIMENTAL

Orally administered once daily.

Drug: TERN-601

TERN-601 Dose 2

EXPERIMENTAL

Orally administered once daily.

Drug: TERN-601

TERN-601 Dose 3

EXPERIMENTAL

Orally administered once daily.

Drug: TERN-601

TERN-601 Dose 4

EXPERIMENTAL

Orally administered once daily.

Drug: TERN-601

Matching Placebo

PLACEBO COMPARATOR

Orally administered once daily.

Other: Matching Placebo

Interventions

TERN-601DRUG

Investigational drug

TERN-601 Dose 1TERN-601 Dose 2TERN-601 Dose 3TERN-601 Dose 4
Matching PlaceboOTHER

Matching placebo

Matching Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

FALCON Research Site

Birmingham, Alabama, 35294, United States

Location

FALCON Research Site

Homewood, Alabama, 35209, United States

Location

FALCON Research Site

Tucson, Arizona, 85712, United States

Location

FALCON Research Site

Spring Valley, California, 91978, United States

Location

FALCON Research Site

Port Orange, Florida, 32127, United States

Location

FALCON Research Site

Louisville, Kentucky, 40213, United States

Location

FALCON Research Site

Marrero, Louisiana, 70072, United States

Location

FALCON Research Site

Boston, Massachusetts, 02114, United States

Location

FALCON Research Site

Rochester, Minnesota, 55905, United States

Location

FALCON Research Site

City of Saint Peters, Missouri, 63303, United States

Location

FALCON Research Site

Beachwood, Ohio, 44122, United States

Location

FALCON Research Site

Medford, Oregon, 97504, United States

Location

FALCON Research Site

Dallas, Texas, 75230, United States

Location

FALCON Research Site

Houston, Texas, 77079, United States

Location

FALCON Research Site

San Antonio, Texas, 78229, United States

Location

FALCON Research Site

St. George, Utah, 84790, United States

Location

FALCON Research Site

Arlington, Virginia, 22206, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

March 7, 2025

Primary Completion

August 19, 2025

Study Completion

September 19, 2025

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(17)