A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation (COURAGE)

May 5, 2026 updated by: Regeneron Pharmaceuticals

A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested.

Part A of the study is focused on healthy participants. Part B and C of the study is focused on participants with obesity.

The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy.

Parts A, B, and C of the study are looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part A Healthy Volunteers

Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1005

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • PRCCI Clinical Research Center
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion (FDI) Clinical Research
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
    • Arizona
      • Phoenix, Arizona, United States, 85044
        • Foothills Research Center Cct Research
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Chula Vista, California, United States, 91911
        • ProSciento
      • Huntington Park, California, United States, 91356
        • Valiance Clinical Research- Huntington Park
      • La Mesa, California, United States, 91941
        • Velocity, San Diego
      • Sacramento, California, United States, 95821
        • Northern California Research
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research
      • Tarzana, California, United States, 91356
        • Metabolic Institute of America
      • Tarzana, California, United States, 91356
        • Valiance Clinical Research
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Southwest General Healthcare Center
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • St. Petersburg, Florida, United States, 33709
        • IMA Clinical Research St. Petersburg
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research, LLC
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida, Inc.
      • Winter Haven, Florida, United States, 33880
        • Clinical Research of Central Florida - Bond Clinic
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Center for Advanced Research and Education
      • Lawrenceville, Georgia, United States, 30046
        • Balanced Life Health Care Solutions
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials LLLP
    • Illinois
      • Springfield, Illinois, United States, 62701
        • Prairie Education and Research Cooperative (PERC)
    • Indiana
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic Center for Research
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research GI, LLC
      • Monroe, Louisiana, United States, 71201
        • IMA Clinical Research Monroe - Armand
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Prime Health and Wellness Clinic
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Center
      • Ridgeland, Mississippi, United States, 39157
        • Sky Integrative Medical Center Skycrng
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
      • Springfield, Missouri, United States, 65807
        • Clinvest Research
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Accellacare Clinical Research, Raleigh Medical Group
      • Salisbury, North Carolina, United States, 28144
        • Accellacare of Salisbury
      • Statesville, North Carolina, United States, 28625
        • Accellacare of Piedmont, Piedmont Healthcare
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
      • Winston-Salem, North Carolina, United States, 27157
        • Javara Incorporated at Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Velocity Clinical Research Inc.
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • AMR Norman
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research LLC
      • Mt. Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pmg Research of Bristol
      • Chattanooga, Tennessee, United States, 37412
        • Chattanooga Medical Research
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville - Merchant Drive
      • Knoxville, Tennessee, United States, 37938
        • PMG Research of Knoxville - Emory Road
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research Dallas
      • El Paso, Texas, United States, 79902
        • Medresearch Inc
      • Fort Worth, Texas, United States, 76164
        • Valley Institute of Research
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria

Part A

  1. Male or female participants age ≥18 to ≤55 years of age at the time of screening

  2. BMI ≥18 and ≤32 kg/m2, at the screening visit

    Part B and Part C

  3. Male or female participants ≥18 to ≤80 years of age at the time of screening
  4. BMI ≥30 kg/m2, at the screening visit
  5. History of 1 or more self-reported unsuccessful dietary attempts to lose weight

Key Exclusion Criteria

  1. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
  2. Previous bariatric surgery or planned bariatric surgery
  3. History of hypertrophic cardiomyopathy
  4. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
  5. Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening)
  6. History of poorly controlled hypertension, as defined in the protocol
  7. Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
  8. Have history of use of marijuana/tetrahydrocannabinol (THC) within 90 days prior to Visit 1 of enrollment and are unwilling to abstain from marijuana/THC use during the trial
  9. Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Part A Randomized 1:1
Drug: Matching Placebo-Part A
Administered IV or SC in Part A
Experimental: Trevogrumab
Part A Randomized 1:1
Drug: Trevogrumab-Part A
Administered IV or SC in Part A
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm A0
Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Drug: Matching Placebo-Garetosmab
Administered IV in Part B
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Experimental: Arm A1
Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Drug: Matching Placebo-Garetosmab
Administered IV in Part B
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm C0
Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Drug: Matching Placebo-Garetosmab
Administered IV in Part B
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm C1
Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Drug: Matching Placebo-Garetosmab
Administered IV in Part B
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm D0
Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Drug: Garetosmab
Administered IV in Part B
Other Names:
  • REGN2477
  • Activin A
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm D1
Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Drug: Garetosmab
Administered IV in Part B
Other Names:
  • REGN2477
  • Activin A
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm B0
Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Drug: Matching Placebo-Garetosmab
Administered IV in Part B
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm B1
Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Drug: Matching Placebo-Garetosmab
Administered IV in Part B
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm 1
Part C Sema and SC placebo Randomized 1:2:2
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Experimental: Arm 2
Part C Sema and SC low dose trevo Randomized 1:2:2
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Matching Placebo-Trevogrumab
Administered SC in Part B and Part C
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8
Experimental: Arm 3
Part C Sema and SC moderate dose trevo Randomized 1:2:2
Drug: Semaglutide
Administered SC in Part B and Part C
Other Names:
  • Wegovy®
Drug: Trevogrumab-Part B and Part C
Administered SC in Part B, Part C
Other Names:
  • REGN1033
  • GDF8

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to week 7
Part A
Baseline to week 7
Severity of TEAEs
Time Frame: Baseline to week 7
Part A
Baseline to week 7
Percent change in total fat mass
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Percent change in total lean mass
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Percent change in body weight
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Percent change in total fat mass
Time Frame: Baseline to week 52
Part C
Baseline to week 52
Percent change in total lean mass
Time Frame: Baseline to week 52
Part C
Baseline to week 52
Percent change in body weight
Time Frame: Baseline to week 52
Part C
Baseline to week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent change in total fat mass
Time Frame: Baseline to week 52
Part B
Baseline to week 52
Percent change in body weight
Time Frame: Baseline to week 52
Part B
Baseline to week 52
Percent change in total lean mass
Time Frame: Baseline to week 52
Part B
Baseline to week 52
Percent change in fasting serum triglycerides
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Percent change in total cholesterol
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Percent change in Apolipoprotein B (Apo B)
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Concentrations of garetosmab in serum over time
Time Frame: Up to 75 weeks
Part B
Up to 75 weeks
Incidence of ADAs to garetosmab after repeated doses over time
Time Frame: Up to 75 weeks
Part B
Up to 75 weeks
Concentrations of trevogrumab in serum over time
Time Frame: Up to 75 weeks
Part A, Part B, and Part C
Up to 75 weeks
Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time
Time Frame: Up to 75 weeks
Part B and Part C
Up to 75 weeks
Incidence of TEAEs
Time Frame: Up to 75 weeks
Part B and Part C
Up to 75 weeks
Severity of TEAEs
Time Frame: Up to 75 weeks
Part B and Part C
Up to 75 weeks
Change in waist circumference (cm)
Time Frame: Baseline to week 26
Part B and Part C
Baseline to week 26
Change in waist circumference (cm)
Time Frame: Baseline to week 52
Part C
Baseline to week 52
Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline to week 26
Part B
Baseline to week 26
Percent change in total fat mass
Time Frame: Baseline to week 26
Part C
Baseline to week 26
Percent change in total lean mass
Time Frame: Baseline to week 26
Part C
Baseline to week 26
Percent change in body weight
Time Frame: Baseline to week 26
Part C
Baseline to week 26
Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time
Time Frame: Up to 75 weeks
Part C
Up to 75 weeks
Magnitude of ADAs to trevogrumab over time
Time Frame: Up to 75 weeks
Part B and Part C
Up to 75 weeks
Magnitude of ADAs to garetosmab over time
Time Frame: Up to 75 weeks
Part B
Up to 75 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R1033-OB-2288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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Locations

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