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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:
Part A Healthy Volunteers
Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Part A Randomized 1:1 |
|
| Trevogrumab | Experimental | Part A Randomized 1:1 |
|
| Arm A0 | Experimental | 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 |
|
| Arm A1 | Experimental | Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1 |
|
| Arm B0 | Experimental | Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trevogrumab-Part A | Drug | Administered IV or SC in Part A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Part A | Baseline to week 7 |
| Severity of TEAEs | Part A | Baseline to week 7 |
| Percent change in total fat mass | Part B | Baseline to week 26 |
| Percent change in total lean mass | Part B | Baseline to week 26 |
| Percent change in body weight | Part B | Baseline to week 26 |
| Percent change in total fat mass | Part C | Baseline to week 52 |
| Percent change in total lean mass | Part C | Baseline to week 52 |
| Percent change in body weight | Part C | Baseline to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of trevogrumab in serum over time | Part A, Part B, and Part C | Up to 75 weeks |
| Percent change in total fat mass | Part B |
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Key Inclusion Criteria
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
Key Exclusion Criteria
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Cullman Clinical Trials |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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
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| Arm B1 | Experimental | Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 |
|
| Arm C0 | Experimental | Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1 |
|
| Arm C1 | Experimental | Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 |
|
| Arm D0 | Experimental | Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1 |
|
| Arm D1 | Experimental | Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1 |
|
| Arm 1 | Experimental | Part C Sema and SC placebo Randomized 1:2:2 |
|
| Arm 2 | Experimental | Part C Sema and SC low dose trevo Randomized 1:2:2 |
|
| Arm 3 | Experimental | Part C Sema and SC moderate dose trevo Randomized 1:2:2 |
|
| Trevogrumab-Part B and Part C | Drug | Administered SC in Part B, Part C |
|
|
| Garetosmab | Drug | Administered IV in Part B |
|
|
| Semaglutide | Drug | Administered SC in Part B and Part C |
|
|
| Matching Placebo-Part A | Drug | Administered IV or SC in Part A |
|
| Matching Placebo-Trevogrumab | Drug | Administered SC in Part B and Part C |
|
| Matching Placebo-Garetosmab | Drug | Administered IV in Part B |
|
| Baseline to week 52 |
| Percent change in total lean mass | Part B | Baseline to week 52 |
| Percent change in body weight | Part B | Baseline to week 52 |
| Change in waist circumference (cm) | Part B and Part C | Baseline to week 26 |
| Change in waist circumference (cm) | Part C | Baseline to week 52 |
| Percent change in fasting serum triglycerides | Part B | Baseline to week 26 |
| Percent change in total cholesterol | Part B | Baseline to week 26 |
| Percent change in Apolipoprotein B (Apo B) | Part B | Baseline to week 26 |
| Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) | Part B | Baseline to week 26 |
| Concentrations of garetosmab in serum over time | Part B | Up to 75 weeks |
| Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time | Part B and Part C | Up to 75 weeks |
| Magnitude of ADAs to trevogrumab over time | Part B and Part C | Up to 75 weeks |
| Incidence of ADAs to garetosmab after repeated doses over time | Part B | Up to 75 weeks |
| Magnitude of ADAs to garetosmab over time | Part B | Up to 75 weeks |
| Incidence of TEAEs | Part B and Part C | Up to 75 weeks |
| Severity of TEAEs | Part B and Part C | Up to 75 weeks |
| Percent change in total fat mass | Part C | Baseline to week 26 |
| Percent change in total lean mass | Part C | Baseline to week 26 |
| Percent change in body weight | Part C | Baseline to week 26 |
| Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time | Part C | Up to 75 weeks |
| Cullman |
| Alabama |
| 35055 |
| United States |
| Foothills Research Center Cct Research | Phoenix | Arizona | 85044 | United States |
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
| ProSciento | Chula Vista | California | 91911 | United States |
| Valiance Clinical Research- Huntington Park | Huntington Park | California | 91356 | United States |
| Velocity, San Diego | La Mesa | California | 91941 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Acclaim Clinical Research | San Diego | California | 92120 | United States |
| Metabolic Institute of America | Tarzana | California | 91356 | United States |
| Valiance Clinical Research | Tarzana | California | 91356 | United States |
| Southwest General Healthcare Center | Fort Myers | Florida | 33907 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| IMA Clinical Research St. Petersburg | St. Petersburg | Florida | 33709 | United States |
| Precision Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33606 | United States |
| Clinical Research of Central Florida - Bond Clinic | Winter Haven | Florida | 33880 | United States |
| Center for Advanced Research and Education | Gainesville | Georgia | 30501 | United States |
| Balanced Life Health Care Solutions | Lawrenceville | Georgia | 30046 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Elite Clinical Trials LLLP | Blackfoot | Idaho | 83221 | United States |
| Prairie Education and Research Cooperative (PERC) | Springfield | Illinois | 62701 | United States |
| The South Bend Clinic Center for Research | South Bend | Indiana | 46617 | United States |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Tandem Clinical Research GI, LLC | Marrero | Louisiana | 70072 | United States |
| IMA Clinical Research Monroe - Armand | Monroe | Louisiana | 71201 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Prime Health and Wellness Clinic | Fayette | Mississippi | 39069 | United States |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | United States |
| Sky Integrative Medical Center Skycrng | Ridgeland | Mississippi | 39157 | United States |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | United States |
| Clinvest Research | Springfield | Missouri | 65807 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Accellacare Clinical Research, Raleigh Medical Group | Raleigh | North Carolina | 27609 | United States |
| Accellacare of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Accellacare of Piedmont, Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| Pmg Research of Wilmington Llc | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Javara Incorporated at Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Velocity Clinical Research Inc. | Cincinnati | Ohio | 45219 | United States |
| AMR Norman | Norman | Oklahoma | 73069 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Tribe Clinical Research Llc | Greenville | South Carolina | 29607 | United States |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29464 | United States |
| Pmg Research of Bristol | Bristol | Tennessee | 37620 | United States |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37412 | United States |
| PMG Research of Knoxville - Merchant Drive | Knoxville | Tennessee | 37912 | United States |
| PMG Research of Knoxville - Emory Road | Knoxville | Tennessee | 37938 | United States |
| Velocity Clinical Research Dallas | Dallas | Texas | 75230 | United States |
| Medresearch Inc | El Paso | Texas | 79902 | United States |
| Valley Institute of Research | Fort Worth | Texas | 76164 | United States |
| Consano Clinical Research | Shavano Park | Texas | 78231 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Fundacion de Investigacion (FDI) Clinical Research | San Juan | 00927 | Puerto Rico |
| PRCCI Clinical Research Center | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C422405 | activin A |
| C000591245 | semaglutide |
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