Trevogrumab-Part A
DrugAdministered IV or SC in Part A
Other names: REGN1033, GDF8
NCT Number: NCT06299098
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)
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Fundacion de Investigacion (FDI) Clinical Research, San Juan, Puerto Rico
Part A Healthy Volunteers
Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria
Part A
Part B and Part C
Key Exclusion Criteria
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Administered IV or SC in Part A
Other names: REGN1033, GDF8
Administered SC in Part B, Part C
Other names: REGN1033, GDF8
Administered IV in Part B
Other names: REGN2477, Activin A
Administered SC in Part B and Part C
Other names: Wegovy®
Administered IV or SC in Part A
Administered SC in Part B and Part C
Administered IV in Part B
Time frame: Baseline to week 7
Part A
Time frame: Baseline to week 7
Part A
Time frame: Baseline to week 26
Part B
Time frame: Baseline to week 26
Part B
Time frame: Baseline to week 26
Part B
Time frame: Baseline to week 52
Part C
Time frame: Baseline to week 52
Part C
Time frame: Baseline to week 52
Part C
Time frame: Up to 75 weeks
Part A, Part B, and Part C
Time frame: Baseline to week 52
Part B
Time frame: Baseline to week 52
Part B
Time frame: Baseline to week 52
Part B
Time frame: Baseline to week 26
Part B and Part C
Time frame: Baseline to week 52
Part C
Time frame: Baseline to week 26
Part B
Time frame: Baseline to week 26
Part B
Time frame: Baseline to week 26
Part B
Time frame: Baseline to week 26
Part B
Time frame: Up to 75 weeks
Part B
Time frame: Up to 75 weeks
Part B and Part C
Time frame: Up to 75 weeks
Part B and Part C
Time frame: Up to 75 weeks
Part B
Time frame: Up to 75 weeks
Part B
Time frame: Up to 75 weeks
Part B and Part C
Time frame: Up to 75 weeks
Part B and Part C
Time frame: Baseline to week 26
Part C
Time frame: Baseline to week 26
Part C
Time frame: Baseline to week 26
Part C
Time frame: Up to 75 weeks
Part C
Regeneron Pharmaceuticals
Industry
A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity
Acronym: COURAGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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