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ObesityPhase 2COURAGENCT06299098

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

A Phase 2 study testing Trevogrumab-Part A, Trevogrumab-Part B and Part C and Garetosmab in people with Obesity, run by Regeneron Pharmaceuticals at 60 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Trevogrumab-Part A, Trevogrumab-Part B and Part C and Garetosmab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,005 participants
Where
60 sitesin 2 countries
Study dates
13 Mar 2024to 21 Oct 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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part A
  • Male or female participants age ≥18 to ≤55 years of age at the time of screening
  • BMI ≥18 and ≤32 kg/m2, at the screening visit
  • Part B and Part C
  • Male or female participants ≥18 to ≤80 years of age at the time of screening
  • BMI ≥30 kg/m2, at the screening visit
  • History of 1 or more self-reported unsuccessful dietary attempts to lose weight

Who cannot join

  • History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
  • Previous bariatric surgery or planned bariatric surgery
  • History of hypertrophic cardiomyopathy
  • Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
  • 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)
  • History of poorly controlled hypertension, as defined in the protocol
Show all 10Show fewer
  • 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
  • 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
  • Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)
  • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial locations and contacts

60 sites in 2 countries.

60 sites in 2 countries

United States58 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Elite Clinical Trials LLLP

    Blackfoot, Idaho, 83221

  • Pmg Research of Bristol

    Bristol, Tennessee, 37620

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37412

  • ProSciento

    Chula Vista, California, 91911

  • Velocity Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Velocity Clinical Research Dallas

    Dallas, Texas, 75230

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Medresearch Inc

    El Paso, Texas, 79902

  • Prime Health and Wellness Clinic

    Fayette, Mississippi, 39069

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907

  • Valley Institute of Research

    Fort Worth, Texas, 76164

  • Center for Advanced Research and Education

    Gainesville, Georgia, 30501

  • Tribe Clinical Research Llc

    Greenville, South Carolina, 29607

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Valiance Clinical Research- Huntington Park

    Huntington Park, California, 91356

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • PMG Research of Knoxville - Merchant Drive

    Knoxville, Tennessee, 37912

  • PMG Research of Knoxville - Emory Road

    Knoxville, Tennessee, 37938

  • Velocity, San Diego

    La Mesa, California, 91941

  • Balanced Life Health Care Solutions

    Lawrenceville, Georgia, 30046

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana, 70072

  • IMA Clinical Research Monroe - Armand

    Monroe, Louisiana, 71201

  • PMG Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • AMR Norman

    Norman, Oklahoma, 73069

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Foothills Research Center Cct Research

    Phoenix, Arizona, 85044

  • Accellacare Clinical Research, Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • Sky Integrative Medical Center Skycrng

    Ridgeland, Mississippi, 39157

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Northern California Research

    Sacramento, California, 95821

  • Accellacare of Salisbury

    Salisbury, North Carolina, 28144

  • Acclaim Clinical Research

    San Diego, California, 92120

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • The South Bend Clinic Center for Research

    South Bend, Indiana, 46617

  • Prairie Education and Research Cooperative (PERC)

    Springfield, Illinois, 62701

  • Clinvest Research

    Springfield, Missouri, 65807

  • IMA Clinical Research St. Petersburg

    St. Petersburg, Florida, 33709

  • Accellacare of Piedmont, Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Valiance Clinical Research

    Tarzana, California, 91356

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Pmg Research of Wilmington Llc

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Javara Incorporated at Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Clinical Research of Central Florida - Bond Clinic

    Winter Haven, Florida, 33880

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

Puerto Rico2 sites

  • Fundacion de Investigacion (FDI) Clinical Research

    San Juan, 00927

  • PRCCI Clinical Research Center

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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.

Read more

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)
Read the detailed description

Part A Healthy Volunteers

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

Conditions
Obesity
Being tested
Trevogrumab-Part A, Trevogrumab-Part B and Part C, Garetosmab, Semaglutide, Matching Placebo-Part A
Keywords
Obesity without diabetes, Quality of weight loss, Fat mass loss, Lean mass loss
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trevogrumab-Part ADrug

    Also called REGN1033, GDF8

    Administered IV or SC in Part A

  • Trevogrumab-Part B and Part CDrug

    Also called REGN1033, GDF8

    Administered SC in Part B, Part C

  • GaretosmabDrug

    Also called REGN2477, Activin A

    Administered IV in Part B

  • SemaglutideDrug

    Also called Wegovy®

    Administered SC in Part B and Part C

  • Matching Placebo-Part ADrug

    Administered IV or SC in Part A

  • Matching Placebo-TrevogrumabDrug

    Administered SC in Part B and Part C

  • Matching Placebo-GaretosmabDrug

    Administered IV in Part B

Study groups in NCT06299098
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPart A Randomized 1:1
Receives: Drug: Matching Placebo-Part A
TrevogrumabExperimentalPart A Randomized 1:1
Receives: Drug: Trevogrumab-Part A
Arm A0ExperimentalPart B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab; Drug: Matching Placebo-Garetosmab
Arm A1ExperimentalPart B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab; Drug: Matching Placebo-Garetosmab
Arm B0ExperimentalPart B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab; Drug: Matching Placebo-Garetosmab
Arm B1ExperimentalPart B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide; Drug: Matching Placebo-Garetosmab
Arm C0ExperimentalPart B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab; Drug: Matching Placebo-Garetosmab
Arm C1ExperimentalPart B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide; Drug: Matching Placebo-Garetosmab
Arm D0ExperimentalPart B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Garetosmab; Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab
Arm D1ExperimentalPart B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Garetosmab; Drug: Semaglutide
Arm 1ExperimentalPart C Sema and SC placebo Randomized 1:2:2
Receives: Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab
Arm 2ExperimentalPart C Sema and SC low dose trevo Randomized 1:2:2
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide; Drug: Matching Placebo-Trevogrumab
Arm 3ExperimentalPart C Sema and SC moderate dose trevo Randomized 1:2:2
Receives: Drug: Trevogrumab-Part B and Part C; Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Part A

    Measured: Baseline to week 7

  2. Severity of TEAEs

    Part A

    Measured: Baseline to week 7

  3. Percent change in total fat mass

    Part B

    Measured: Baseline to week 26

  4. Percent change in total lean mass

    Part B

    Measured: Baseline to week 26

  5. Percent change in body weight

    Part B

    Measured: Baseline to week 26

  6. Percent change in total fat mass

    Part C

    Measured: Baseline to week 52

  7. Percent change in total lean mass

    Part C

    Measured: Baseline to week 52

  8. Percent change in body weight

    Part C

    Measured: Baseline to week 52

Secondary outcomes (21)

  1. Concentrations of trevogrumab in serum over time

    Part A, Part B, and Part C

    Measured: Up to 75 weeks

  2. Percent change in total fat mass

    Part B

    Measured: Baseline to week 52

  3. Percent change in total lean mass

    Part B

    Measured: Baseline to week 52

  4. Percent change in body weight

    Part B

    Measured: Baseline to week 52

  5. Change in waist circumference (cm)

    Part B and Part C

    Measured: Baseline to week 26

  6. Change in waist circumference (cm)

    Part C

    Measured: Baseline to week 52

  7. Percent change in fasting serum triglycerides

    Part B

    Measured: Baseline to week 26

  8. Percent change in total cholesterol

    Part B

    Measured: Baseline to week 26

  9. Percent change in Apolipoprotein B (Apo B)

    Part B

    Measured: Baseline to week 26

  10. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Part B

    Measured: Baseline to week 26

  11. Concentrations of garetosmab in serum over time

    Part B

    Measured: Up to 75 weeks

  12. Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time

    Part B and Part C

    Measured: Up to 75 weeks

  13. Magnitude of ADAs to trevogrumab over time

    Part B and Part C

    Measured: Up to 75 weeks

  14. Incidence of ADAs to garetosmab after repeated doses over time

    Part B

    Measured: Up to 75 weeks

  15. Magnitude of ADAs to garetosmab over time

    Part B

    Measured: Up to 75 weeks

  16. Incidence of TEAEs

    Part B and Part C

    Measured: Up to 75 weeks

  17. Severity of TEAEs

    Part B and Part C

    Measured: Up to 75 weeks

  18. Percent change in total fat mass

    Part C

    Measured: Baseline to week 26

  19. Percent change in total lean mass

    Part C

    Measured: Baseline to week 26

  20. Percent change in body weight

    Part C

    Measured: Baseline to week 26

  21. Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time

    Part C

    Measured: Up to 75 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start13 Mar 2024
  3. Primary completion16 Jun 2026
  4. Study completion21 Oct 2026 (estimated)

Resources

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06299098
Sponsor's protocol ID
R1033-OB-2288
Acronym
COURAGE
Status last verified
Aug 2026
First submitted
1 Mar 2024
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trevogrumab-Part A, Trevogrumab-Part B and Part C and Garetosmab in people with Obesity, run by Regeneron Pharmaceuticals at 60 sites in 2 countries.

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 7 inclusion and 10 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Puerto Rico. 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?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline to week 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06299098.

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 1 Sep 2026.

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