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

Terns Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Overweight or Obesity

Treatments: Other: Matching Placebo; Drug: TERN-601

Study type: Interventional

Funder types: Industry

Identifiers

NCT06854952

TERN601-2003

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 5 patient groups, including a placebo group

TERN-601 Dose 1

Experimental group

Description:

Orally administered once daily.

Treatment:

Drug: TERN-601

TERN-601 Dose 2

Experimental group

Description:

Orally administered once daily.

Treatment:

Drug: TERN-601

TERN-601 Dose 3

Experimental group

Description:

Orally administered once daily.

Treatment:

Drug: TERN-601

TERN-601 Dose 4

Experimental group

Description:

Orally administered once daily.

Treatment:

Drug: TERN-601

Matching Placebo

Placebo Comparator group

Description:

Orally administered once daily.

Treatment:

Other: Matching Placebo