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A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
Lead sponsor
Assets
CagriSema / cagrilintide / Semaglutide
Listed sites
36
Recruiting sites
—
Enrollment
400
estimated
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Body weight, % change
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
Inclusion criteria
Exclusion criteria
Endpoints (60)
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
20 endpointsRelative change in body weight
Time frame:From baseline (week 0) to week 104
Body weight, % change
percent change from baseline, improvement
Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
Time frame:From baseline (week 0) to week 104
≥20% weight-loss responders
threshold achievement, improvement
Number of participants who achieve >= 25 percent body weight reduction
Time frame:From baseline (week 0) to week 104
≥25% weight-loss responders
threshold achievement, improvement
Number of participants who achieve >= 30 percent body weight reduction
Time frame:From baseline (week 0) to week 104
≥25% weight-loss responders
threshold achievement, improvement
Change in waist circumference
Time frame:From baseline (week 0) to week 104
Waist circumference, change
change from baseline, improvement
Change in waist to height ratio
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Change in Body Mass Index (BMI)
Time frame:From baseline (week 0) to week 104
BMI, change
change from baseline, improvement
Number of participants who achieve BMI less than 30 kg/m^2
Time frame:At week 104
threshold achievement, improvement
Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])
Time frame:From baseline (week 0) to week 104
Total fat mass
change from baseline, improvement
Change in total fat mass by DXA relative to total body mass (kg)
Time frame:From baseline (week 0) to week 104
Total fat mass
change from baseline, improvement
Change in total fat mass by DXA absolute to total body mass (percentage points)
Time frame:From baseline (week 0) to week 104
Total fat mass
change from baseline, improvement
Change in total fat mass by DXA relative to total body mass (percentage points)
Time frame:From baseline (week 0) to week 104
Total fat mass
change from baseline, improvement
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)
Time frame:From baseline (week 0) to week 104
Visceral fat, change
percent change from baseline, improvement
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)
Time frame:From baseline (week 0) to week 104
Visceral fat, change
percent change from baseline, improvement
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)
Time frame:From baseline (week 0) to week 104
Visceral fat, change
percent change from baseline, improvement
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)
Time frame:From baseline (week 0) to week 104
Visceral fat, change
change from baseline, improvement
Change in lean body mass by DXA absolute to total body mass (kg)
Time frame:From baseline (week 0) to week 104
Lean mass
change from baseline, improvement
Change in lean body mass by DXA relative to total body mass (kg)
Time frame:From baseline (week 0) to week 104
Lean mass
change from baseline, improvement
Change in lean body mass by DXA absolute to total body mass (percentage points)
Time frame:From baseline (week 0) to week 104
Lean mass
change from baseline, improvement
Change in lean body mass by DXA relative to total body mass (percentage points)
Time frame:From baseline (week 0) to week 104
Lean mass
change from baseline, improvement
Glycemic / diabetes
11 endpointsChange in Glycated Haemoglobin (HbA1c) (percentage points)
Time frame:From baseline (week 0) to week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c (millimoles per mole [mmol/mol])
Time frame:From baseline (week 0) to week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Time frame:From baseline (week 0) to week 104
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in FPG (milligrams per deciliter [mg/dL])
Time frame:From baseline (week 0) to week 104
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Time frame:From baseline (week 0) to week 104
HbA1c <5.7% achievement
threshold achievement, improvement
componentsHbA1c <5.7% achievement, Fasting glucose, change
Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Time frame:From baseline (week 0) to week 104
T2DM prevention
threshold achievement, event
componentsHbA1c <6.5% achievement, Fasting glucose, change
Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Time frame:From baseline (week 0) to week 104
time to event, improvement
Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Time frame:From baseline (week 0) to week 104
Time to T2DM onset
time to event, event
componentsHbA1c <6.5% achievement, Fasting glucose, change
Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline
Time frame:From baseline (week 0) to week 104
threshold achievement, event
componentsHbA1c <5.7% achievement, Fasting glucose, change
Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline
Time frame:From baseline (week 0) to week 104
Time to T2DM onset
event count, event
Time to T2D diagnosis as per ADA guideline
Time frame:From baseline (week 0) to week 104
Time to T2DM onset
time to event, event
Cardiometabolic biomarkers
11 endpointsChange in Systolic Blood Pressure (SBP)
Time frame:From baseline (week 0) to week 104
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Ratio to Baseline in Lipids: Total Cholesterol
Time frame:From baseline (week 0) to week 104
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Time frame:From baseline (week 0) to week 104
HDL-C, change
ratio, improvement
LOINC 2085-9
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Time frame:From baseline (week 0) to week 104
LDL-C, change
ratio, improvement
LOINC 13457-7
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame:From baseline (week 0) to week 104
VLDL, change
ratio, improvement
Ratio to Baseline in Lipids: Triglycerides
Time frame:From baseline (week 0) to week 104
Triglycerides, change
ratio, improvement
LOINC 2571-8
Ratio to Baseline in Lipids: Free fatty acids
Time frame:From baseline (week 0) to week 104
Free fatty acids, change
ratio, improvement
Ratio to Baseline in Lipids: Non-HDL cholesterol
Time frame:From baseline (week 0) to week 104
Non-HDL cholesterol, change
ratio, improvement
Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)
Time frame:From baseline (week 0) to week 104
threshold achievement, improvement
componentsSystolic BP, change, HbA1c, change, LDL-C, change
Ratio to baseline in C-reactive protein (CRP)
Time frame:From baseline (week 0) to week 104
hs-CRP, change
ratio, improvement
LOINC 30522-7
Patient-reported / QoL
12 endpointsChange in Short Form (SF)-36 Physical functioning score
Time frame:From baseline (week 0) to week 104
SF-36 physical
change from baseline, improvement
Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT): Physical Function Score
Time frame:From baseline (week 0) to week 104
IWQOL-Lite physical
change from baseline, improvement
Change in IWQOL-Lite-CT: Physical Score
Time frame:From baseline (week 0) to week 104
IWQOL-Lite physical
change from baseline, improvement
Change in IWQOL-Lite-CT: Psychosocial score
Time frame:From baseline (week 0) to week 104
IWQOL-Lite physical
change from baseline, improvement
Change in IWQOL-Lite-CT: Total score
Time frame:From baseline (week 0) to week 104
IWQOL-Lite total
change from baseline, improvement
Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score
Time frame:From baseline (week 0) to week 104
IWQOL-Lite total
change from baseline, improvement
Change in Control of Eating questionnaire (CoEQ): Craving Control score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Change in CoEQ: Positive Mood score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Change in CoEQ: Craving for Sweets score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Change in CoEQ: Craving for Savoury score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Change in CoEQ: Hunger score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Change in CoEQ: Satiety score
Time frame:From baseline (week 0) to week 104
change from baseline, improvement
Safety / tolerability / PK
6 endpointsCagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Adverse Events (TEAEs)
Time frame:From baseline (week 0) to week 104
Treatment-emergent AEs (any)
event count, event
CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Serious Adverse Events (TESAEs)
Time frame:From baseline (week 0) to week 104
Serious AEs (any)
event count, event
CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TEAEs
Time frame:From week 104 to end of study (week 162)
Treatment-emergent AEs (any)
event count, event
CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TESAEs
Time frame:From week 104 to end of study (week 162)
Serious AEs (any)
event count, event
CagriSema 2.4 mg/2.4 mg: Number of TEAEs
Time frame:From week 104 to end of study (week 162)
Treatment-emergent AEs (any)
event count, event
CagriSema 2.4 mg/2.4 mg: Number of TESAEs
Time frame:From week 104 to end of study (week 162)
Serious AEs (any)
event count, event
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.