ObesityPhase 2NCT07281495
Taldefgrobep Alfa in Adults With Overweight and Obesity
A Phase 2 study testing Taldefgrobep Alfa in people with Obesity and Overweight, run by Biohaven Therapeutics Ltd. at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Taldefgrobep Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 20 sitesUnited States
- Study dates
- 24 Nov 2025to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Stable body weight and stable physical activity within 3 months prior to screening per participant self-report.
- All participants must adhere to protocol contraception requirements
Who cannot join
- History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening
- Non-ambulatory participants, defined as unable to take at least 10 steps independently.
- Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed.
- Participation in another investigational clinical trial while participating in this clinical trial
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Site-004
Arlington, Virginia, 22205
Site-005
Austin, Texas, 78745
Site-010
Baton Rouge, Louisiana, 70808
Site-007
Chicago, Illinois, 60625
Site-001
Chula Vista, California, 91911
Site-006
City of Saint Peters, Missouri, 63303
Site-002
Fargo, North Dakota, 58104
Site-016
Indianapolis, Indiana, 46254
Site-012
McKinney, Texas, 75069
Site-009
Metairie, Louisiana, 70006
Site-019
Monroe, North Carolina, 28112
Site-014
Montclair, California, 97163
Site-017
North Charleston, South Carolina, 29405
Site-020
Orlando, Florida, 32804
Site-008
Palm Springs, Florida, 33461
Site-011
Sacramento, California, 95821
Site-013
San Antonio, Texas, 78229
Site-003
Springfield, Missouri, 65807
Site-015
St. Petersburg, Florida, 33704
Site-018
Tustin, California, 92780
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With Open-Label Extension to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Taldefgrobep Alfa in Adults Living With Overweight and Obesity
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
- Obesity, Overweight
- Being tested
- Taldefgrobep Alfa, Placebo
- Keywords
- myostatin, activin
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taldefgrobep AlfaDrug
Also called BHV-2000
Subcutaneous injection administered once each week
PlaceboDrug
Subcutaneous injection (matching placebo) administered once each week
Taldefgrobep AlfaDrug
Also called BHV-2000
Subcutaneous injection administered once every 4 weeks
PlaceboDrug
Subcutaneous injection (matching placebo) administered once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Taldefgrobep Alpha once weekly | Experimental | Not described Receives: Drug: Taldefgrobep Alfa |
| Placebo once weekly | Placebo comparator | Not described Receives: Drug: Placebo |
| Taldefgrobep Alpha once every 4 weeks | Experimental | Not described Receives: Drug: Taldefgrobep Alfa |
| Placebo once every 4 weeks | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total body weight from Baseline to Week 24
Measured: Baseline to Week 24
Secondary outcomes (3)
Percent change in total body fat mass from Baseline to Week 24
Measured: Baseline to Week 24
Percent change in total body lean mass from Baseline to Week 24
Measured: Baseline to Week 24
Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities
Measured: Through week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start24 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281495
- Sponsor's protocol ID
- BHV2000-202
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With Open-Label Extension to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Taldefgrobep Alfa in Adults Living With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07281495
- Acronym / sponsor ID
- BHV2000-202
- Conditions
- Obesity, Overweight
- Keywords
- myostatin, activin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Taldefgrobep Alpha once weekly | Experimental | Drug: Taldefgrobep Alfa |
| Placebo once weekly | Placebo comparator | Drug: Placebo |
| Taldefgrobep Alpha once every 4 weeks | Experimental | Drug: Taldefgrobep Alfa |
| Placebo once every 4 weeks | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Stable body weight and stable physical activity within 3 months prior to screening per participant self-report.
- All participants must adhere to protocol contraception requirements
Key exclusion criteria (4 listed)
- History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening
- Non-ambulatory participants, defined as unable to take at least 10 steps independently.
- Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed.
- Participation in another investigational clinical trial while participating in this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taldefgrobep AlfaAlso: BHV-2000Subcutaneous injection administered once each week | Drug | Taldefgrobep Alpha once weekly |
| PlaceboSubcutaneous injection (matching placebo) administered once each week | Drug | Placebo once weekly |
| Taldefgrobep AlfaAlso: BHV-2000Subcutaneous injection administered once every 4 weeks | Drug | Taldefgrobep Alpha once every 4 weeks |
| PlaceboSubcutaneous injection (matching placebo) administered once every 4 weeks | Drug | Placebo once every 4 weeks |
Primary outcome
Percent change in total body weight from Baseline to Week 24
Time frame: Baseline to Week 24
3 secondary outcomes
Percent change in total body fat mass from Baseline to Week 24
Time frame: Baseline to Week 24
Percent change in total body lean mass from Baseline to Week 24
Time frame: Baseline to Week 24
Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities
Time frame: Through week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taldefgrobep Alfa in people with Obesity and Overweight, run by Biohaven Therapeutics Ltd. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total body weight from Baseline to Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.