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COURAGE
Active not recruitingPhase 2A 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 Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
60
Recruiting sites
—
Enrollment
1,005
actual
Study population
Healthy volunteers, Obesity / overweight
Key I/E criterion
•BMI 18-32
Primary endpoints
•Treatment-emergent AEs (any)•Total fat mass•Lean mass
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
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
Endpoints (29)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
14 endpointsPercent change in total fat mass
Time frame:Baseline to week 26
Total fat mass
percent change from baseline, improvement
Percent change in total lean mass
Time frame:Baseline to week 26
Lean mass
percent change from baseline, improvement
Percent change in body weight
Time frame:Baseline to week 26
Body weight, % change
percent change from baseline, improvement
Percent change in total fat mass
Time frame:Baseline to week 52
Total fat mass
percent change from baseline, improvement
Percent change in total lean mass
Time frame:Baseline to week 52
Lean mass
percent change from baseline, improvement
Percent change in body weight
Time frame:Baseline to week 52
Body weight, % change
percent change from baseline, improvement
Percent change in total fat mass
Time frame:Baseline to week 52
Total fat mass
percent change from baseline, improvement
Percent change in total lean mass
Time frame:Baseline to week 52
Lean mass
percent change from baseline, improvement
Percent change in body weight
Time frame:Baseline to week 52
Body weight, % change
percent change from baseline, improvement
Change in waist circumference (cm)
Time frame:Baseline to week 26
Waist circumference, change
change from baseline, improvement
Change in waist circumference (cm)
Time frame:Baseline to week 52
Waist circumference, change
change from baseline, improvement
Percent change in total fat mass
Time frame:Baseline to week 26
Total fat mass
percent change from baseline, improvement
Percent change in total lean mass
Time frame:Baseline to week 26
Lean mass
percent change from baseline, improvement
Percent change in body weight
Time frame:Baseline to week 26
Body weight, % change
percent change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsPercent change in fasting serum triglycerides
Time frame:Baseline to week 26
Triglycerides, change
percent change from baseline, improvement
LOINC 2571-8
Percent change in total cholesterol
Time frame:Baseline to week 26
Total cholesterol, change
percent change from baseline, improvement
LOINC 2093-3
Percent change in Apolipoprotein B (Apo B)
Time frame:Baseline to week 26
ApoB, change
percent change from baseline, improvement
Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame:Baseline to week 26
LDL-C, change
percent change from baseline, improvement
LOINC 13457-7
Safety / tolerability / PK
10 endpointsIncidence of treatment-emergent adverse events (TEAEs)
Time frame:Baseline to week 7
Treatment-emergent AEs (any)
event count, event
Severity of TEAEs
Time frame:Baseline to week 7
Treatment-emergent AEs (any)
descriptive
Concentrations of trevogrumab in serum over time
Time frame:Up to 75 weeks
Plasma concentration (steady state)
concentration, descriptive
Concentrations of garetosmab in serum over time
Time frame:Up to 75 weeks
Plasma concentration (steady state)
concentration, descriptive
Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time
Time frame:Up to 75 weeks
Immunogenicity (ADA)
descriptive
Magnitude of ADAs to trevogrumab over time
Time frame:Up to 75 weeks
Immunogenicity (ADA)
descriptive
Incidence of ADAs to garetosmab after repeated doses over time
Time frame:Up to 75 weeks
Immunogenicity (ADA)
descriptive
Magnitude of ADAs to garetosmab over time
Time frame:Up to 75 weeks
Immunogenicity (ADA)
descriptive
Incidence of TEAEs
Time frame:Up to 75 weeks
Treatment-emergent AEs (any)
event count, event
Severity of TEAEs
Time frame:Up to 75 weeks
Treatment-emergent AEs (any)
descriptive
Other (unclassified)
1 endpointConcentration of total Growth Differentiation Factor (GDF) 8 in serum over time
Time frame:Up to 75 weeks
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.