Clinical trial NCT06854952: A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity
Official title: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Overweight or Obesity
Keywords: overweight
obesity
obese
glucagon-like peptide-1 receptor agonist
GLP-1 receptor agonist
GLP-1
Lead sponsor: Terns, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

      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

Primary outcomes:
measure: Percent Change in Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Body Weight
timeFrame: 12 weeks
measure: ≥ 5% Weight Loss
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: FALCON Research Site
state: Alabama
city: Homewood
country: United States
facility: FALCON Research Site
state: Alabama
city: Tucson
country: United States
facility: FALCON Research Site
state: Arizona
city: Spring Valley
country: United States
facility: FALCON Research Site
state: California
city: Port Orange
country: United States
facility: FALCON Research Site
state: Florida
city: Louisville
country: United States
facility: FALCON Research Site
state: Kentucky
city: Marrero
country: United States
facility: FALCON Research Site
state: Louisiana
city: Boston
country: United States
facility: FALCON Research Site
state: Massachusetts
city: Rochester
country: United States
facility: FALCON Research Site
state: Minnesota
city: Saint Peters
country: United States
facility: FALCON Research Site
state: Missouri
city: Beachwood
country: United States
facility: FALCON Research Site
state: Ohio
city: Medford
country: United States
facility: FALCON Research Site
state: Oregon
city: Dallas
country: United States
facility: FALCON Research Site
state: Texas
city: Houston
country: United States
facility: FALCON Research Site
state: Texas
city: San Antonio
country: United States
facility: FALCON Research Site
state: Texas
city: Saint George
country: United States
facility: FALCON Research Site
state: Utah
city: Arlington
country: United States
facility: FALCON Research Site
state: Virginia
Study officials:
References: