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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Taldefgrobep Alpha once weekly
  • Drug: Taldefgrobep Alfa
    Subcutaneous injection administered once each week
    Other names:
    • BHV-2000
Placebo Comparator
Placebo once weekly
  • Drug: Placebo
    Subcutaneous injection (matching placebo) administered once each week
Experimental
Taldefgrobep Alpha once every 4 weeks
  • Drug: Taldefgrobep Alfa
    Subcutaneous injection administered once every 4 weeks
    Other names:
    • BHV-2000
Placebo Comparator
Placebo once every 4 weeks
  • Drug: Placebo
    Subcutaneous injection (matching placebo) administered once every 4 weeks

Recruiting Locations

Site-001
Chula Vista 5336899, California 5332921 91911

Site-014
Montclair 5374232, California 5332921 97163

Site-011
Sacramento 5389489, California 5332921 95821

Site-018
Tustin 5404119, California 5332921 92780

Site-008
Palm Springs 4167583, Florida 4155751 33461

Site-015
St. Petersburg 4171563, Florida 4155751 33704

Site-007
Chicago 4887398, Illinois 4896861 60625

Site-016
Indianapolis 4259418, Indiana 4921868 46254

Site-010
Baton Rouge 4315588, Louisiana 4331987 70808

Site-009
Metairie 4333177, Louisiana 4331987 70006

Site-006
City of Saint Peters 4407237, Missouri 4398678 63303

Site-003
Springfield 4409896, Missouri 4398678 65807

Site-019
Monroe 4479946, North Carolina 4482348 28112

Site-002
Fargo 5059163, North Dakota 5690763 58104

Site-017
North Charleston 4589387, South Carolina 4597040 29405

Site-005
Austin 4671654, Texas 4736286 78745

Site-012
McKinney 4710178, Texas 4736286 75069

Site-013
San Antonio 4726206, Texas 4736286 78229

Site-004
Arlington 4744709, Virginia 6254928 22205

More Details

Status
Recruiting
Sponsor
Biohaven Therapeutics Ltd.

Study Contact

Chief Medical Officer
203-404-0410
clinicaltrials@biohavenpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.