Taldefgrobep Alfa in Adults With Overweight and Obesity

Biohaven

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Taldefgrobep Alfa; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07281495

BHV2000-202

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled, multiple dose study to evaluate the efficacy, safety, and tolerability of taldefgrobep alfa in adults with overweight and obesity, with an open-label extension.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. a. BMI > 30 kg/m2 and BMI < 42 kg/m2, OR b. BMI ≥ 27 kg/m2 and BMI <30 kg/m2 with at least one weight-related co-morbidity
2. History of at least one self-reported unsuccessful dietary effort to lose body weight.
3. Stable body weight and stable physical activity within 3 months prior to screening per participant self-report.
4. All participants must adhere to protocol contraception requirements

Key Exclusion Criteria:

1. History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening
2. Non-ambulatory participants, defined as unable to take at least 10 steps independently.
3. Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed.
4. Participation in another investigational clinical trial while participating in this clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 4 patient groups, including a placebo group

Taldefgrobep Alpha once weekly

Experimental group

Treatment:

Drug: Taldefgrobep Alfa

Drug: Taldefgrobep Alfa

Placebo once weekly

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Taldefgrobep Alpha once every 4 weeks

Experimental group

Treatment:

Drug: Taldefgrobep Alfa

Drug: Taldefgrobep Alfa

Placebo once every 4 weeks

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo