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Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
Lead sponsor
Assets
CagriSema / cagrilintide / Liraglutide
Listed sites
54
Recruiting sites
—
Enrollment
706
actual
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 (54)
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
10 endpointsChange in Body Weight (%)
Time frame:From baseline (week 0) to week 26
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage point of body weight | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -6.1 | — |
| Cagrilintide 0.6 mg | -6.9 | — |
| Cagrilintide 1.2 mg | -8.5 | — |
| Cagrilintide 2.4 mg | -9.5 | — |
| Cagrilintide 4.5 mg | -10.8 | — |
| Liraglutide 3.0 mg | -8.5 | — |
| Pooled Placebo | -3.0 | — |
Change in Body Weight (%)
Time frame:From baseline (week 0) to week 26
Body weight, % change
percent change from baseline, improvement
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
Time frame:Week 26
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 57.47 | — |
| Cagrilintide 0.6 mg | 61.98 | — |
| Cagrilintide 1.2 mg | 75.84 | — |
| Cagrilintide 2.4 mg | 74.12 | — |
| Cagrilintide 4.5 mg | 88.74 | — |
| Liraglutide 3.0 mg | 76.16 | — |
| Pooled Placebo | 30.90 | — |
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
Time frame:Week 26
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 15.28 | — |
| Cagrilintide 0.6 mg | 24.06 | — |
| Cagrilintide 1.2 mg | 35.79 | — |
| Cagrilintide 2.4 mg | 43.97 | — |
| Cagrilintide 4.5 mg | 53.49 | — |
| Liraglutide 3.0 mg | 39.43 | — |
| Pooled Placebo | 10.44 | — |
Change in Body Weight (Kg)
Time frame:From baseline (week 0) to week 26
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms (kg) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -6.6 | — |
| Cagrilintide 0.6 mg | -7.1 | — |
| Cagrilintide 1.2 mg | -9.0 | — |
| Cagrilintide 2.4 mg | -10.1 | — |
| Cagrilintide 4.5 mg | -11.8 | — |
| Liraglutide 3.0 mg | -9.1 | — |
| Pooled Placebo | -3.2 | — |
Change in Waist Circumference
Time frame:From baseline (week 0) to week 26
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), centimeters (cm) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -6.2 | — |
| Cagrilintide 0.6 mg | -6.2 | — |
| Cagrilintide 1.2 mg | -7.7 | — |
| Cagrilintide 2.4 mg | -8.1 | — |
| Cagrilintide 4.5 mg | -9.5 | — |
| Liraglutide 3.0 mg | -7.4 | — |
| Pooled Placebo | -3.4 | — |
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
Time frame:Week 26
≥5% weight-loss responders
threshold achievement, improvement
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
Time frame:Week 26
≥10% weight-loss responders
threshold achievement, improvement
Change in Body Weight (Kg)
Time frame:From baseline (week 0) to week 26
Body weight, absolute change (kg)
change from baseline, improvement
Change in Waist Circumference
Time frame:From baseline (week 0) to week 26
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
14 endpointsChange in Glycosylated Haemoglobin (HbA1c) (%-Point)
Time frame:From baseline (week 0) to week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage point of HbA1c | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 0.0 | — |
| Cagrilintide 0.6 mg | -0.1 | — |
| Cagrilintide 1.2 mg | -0.1 | — |
| Cagrilintide 2.4 mg | -0.1 | — |
| Cagrilintide 4.5 mg | -0.1 | — |
| Liraglutide 3.0 mg | -0.3 | — |
| Pooled Placebo | -0.1 | — |
Change in HbA1c (mmol/Mol)
Time frame:From baseline (week 0) to week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), mmol/mol | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -0.5 | — |
| Cagrilintide 0.6 mg | -0.6 | — |
| Cagrilintide 1.2 mg | -0.8 | — |
| Cagrilintide 2.4 mg | -1.0 | — |
| Cagrilintide 4.5 mg | -1.2 | — |
| Liraglutide 3.0 mg | -2.9 | — |
| Pooled Placebo | -0.6 | — |
Change in Fasting Plasma Glucose (FPG) (mmol/L)
Time frame:From baseline (week 0) to week 26
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 0.0 | — |
| Cagrilintide 0.6 mg | 0.0 | — |
| Cagrilintide 1.2 mg | -0.2 | — |
| Cagrilintide 2.4 mg | 0.0 | — |
| Cagrilintide 4.5 mg | -0.2 | — |
| Liraglutide 3.0 mg | -0.5 | — |
| Pooled Placebo | 0.0 | — |
Change in FPG (mg/dL)
Time frame:From baseline (week 0) to week 26
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -0.7 | — |
| Cagrilintide 0.6 mg | -0.6 | — |
| Cagrilintide 1.2 mg | -3.2 | — |
| Cagrilintide 2.4 mg | 0.0 | — |
| Cagrilintide 4.5 mg | -3.7 | — |
| Liraglutide 3.0 mg | -9.5 | — |
| Pooled Placebo | -0.5 | — |
Change in Fasting Insulin
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Posted result
| Group | Value (mean), Picomoles per liter (pmol/L) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mgWeek 0 | 103.88 | — |
| Week 26 | 93.07 | — |
| Cagrilintide 0.6 mgWeek 0 | 97.43 | — |
| Week 26 | 82.98 | — |
| Cagrilintide 1.2 mgWeek 0 | 96.44 | — |
| Week 26 | 79.39 | — |
| Cagrilintide 2.4 mgWeek 0 | 90.05 | — |
| Week 26 | 71.22 | — |
| Cagrilintide 4.5 mgWeek 0 | 109.99 | — |
| Week 26 | 78.67 | — |
| Liraglutide 3.0 mgWeek 0 | 95.80 | — |
| Week 26 | 79.00 | — |
| Pooled PlaceboWeek 0 | 105.77 | — |
| Week 26 | 86.55 | — |
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:From baseline (week 0) to week 26
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change of HOMA-IR | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -0.05 | — |
| Cagrilintide 0.6 mg | -0.60 | — |
| Cagrilintide 1.2 mg | -1.09 | — |
| Cagrilintide 2.4 mg | -0.72 | — |
| Cagrilintide 4.5 mg | -2.12 | — |
| Liraglutide 3.0 mg | -0.91 | — |
| Pooled Placebo | -0.71 | — |
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Posted result
| Group | Value (mean), Percentage of Beta Cell Function | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -10.7 | — |
| Cagrilintide 0.6 mg | -20.0 | — |
| Cagrilintide 1.2 mg | -18.3 | — |
| Cagrilintide 2.4 mg | -29.9 | — |
| Cagrilintide 4.5 mg | -39.7 | — |
| Liraglutide 3.0 mg | 16.3 | — |
| Pooled Placebo | -26.0 | — |
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Time frame:From baseline (week 0) to week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c (mmol/Mol)
Time frame:From baseline (week 0) to week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose (FPG) (mmol/L)
Time frame:From baseline (week 0) to week 26
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in FPG (mg/dL)
Time frame:From baseline (week 0) to week 26
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Fasting Insulin
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:From baseline (week 0) to week 26
HOMA-IR (insulin sensitivity)
percent change from baseline, improvement
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Cardiometabolic biomarkers
22 endpointsChange in Total Cholesterol
Time frame:From baseline (week 0) to week 26
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Posted result
| Group | Value (mean), Milligrams per deciliter (mg/dL) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 3.9 | — |
| Cagrilintide 0.6 mg | -1.8 | — |
| Cagrilintide 1.2 mg | -3.1 | — |
| Cagrilintide 2.4 mg | -2.9 | — |
| Cagrilintide 4.5 mg | -5.4 | — |
| Liraglutide 3.0 mg | -9.4 | — |
| Pooled Placebo | 0.1 | — |
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame:From baseline (week 0) to week 26
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 1.5 | — |
| Cagrilintide 0.6 mg | 1.9 | — |
| Cagrilintide 1.2 mg | 1.1 | — |
| Cagrilintide 2.4 mg | 1.8 | — |
| Cagrilintide 4.5 mg | 2.6 | — |
| Liraglutide 3.0 mg | 0.8 | — |
| Pooled Placebo | 0.1 | — |
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame:From baseline (week 0) to week 26
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 5.2 | — |
| Cagrilintide 0.6 mg | -0.3 | — |
| Cagrilintide 1.2 mg | -0.5 | — |
| Cagrilintide 2.4 mg | -0.9 | — |
| Cagrilintide 4.5 mg | -2.7 | — |
| Liraglutide 3.0 mg | -5.4 | — |
| Pooled Placebo | -1.0 | — |
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame:From baseline (week 0) to week 26
VLDL, change
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -2.8 | — |
| Cagrilintide 0.6 mg | -3.4 | — |
| Cagrilintide 1.2 mg | -3.6 | — |
| Cagrilintide 2.4 mg | -3.8 | — |
| Cagrilintide 4.5 mg | -5.4 | — |
| Liraglutide 3.0 mg | -4.9 | — |
| Pooled Placebo | 0.9 | — |
Change in Triglycerides
Time frame:From baseline (week 0) to week 26
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -13.29 | — |
| Cagrilintide 0.6 mg | -16.25 | — |
| Cagrilintide 1.2 mg | -17.98 | — |
| Cagrilintide 2.4 mg | -19.24 | — |
| Cagrilintide 4.5 mg | -30.35 | — |
| Liraglutide 3.0 mg | -25.42 | — |
| Pooled Placebo | 8.17 | — |
Change in Diastolic Blood Pressure (DBP)
Time frame:From baseline (week 0) to week 26
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), millimeter of mercury (mmHg) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -2.2 | — |
| Cagrilintide 0.6 mg | 0.8 | — |
| Cagrilintide 1.2 mg | -1.3 | — |
| Cagrilintide 2.4 mg | -1.2 | — |
| Cagrilintide 4.5 mg | -1.8 | — |
| Pooled Placebo | -2.6 | — |
Change in Systolic Blood Pressure (SBP)
Time frame:From baseline (week 0) to week 26
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -4.9 | — |
| Cagrilintide 0.6 mg | -0.9 | — |
| Cagrilintide 1.2 mg | -4.9 | — |
| Cagrilintide 2.4 mg | -5.0 | — |
| Cagrilintide 4.5 mg | -6.2 | — |
| Pooled Placebo | -3.8 | — |
Change in Pulse
Time frame:From baseline (week 0) to week 26
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), beats per minute | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | -2.1 | — |
| Cagrilintide 0.6 mg | -0.6 | — |
| Cagrilintide 1.2 mg | -1.2 | — |
| Cagrilintide 2.4 mg | -2.0 | — |
| Cagrilintide 4.5 mg | -4.5 | — |
| Liraglutide 3.0 mg | 1.6 | — |
| Pooled Placebo | -0.1 | — |
Change in High Sensitivity C-reactive Protein (hsCRP)
Time frame:From baseline (week 0) to week 26
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Value (mean), milligrams per liter (mg/L) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mgWeek 0 | 4.5 | — |
| Week 26 | 3.5 | — |
| Cagrilintide 0.6 mgWeek 0 | 4.6 | — |
| Week 26 | 3.4 | — |
| Cagrilintide 1.2 mgWeek 0 | 4.5 | — |
| Week 26 | 4.6 | — |
| Cagrilintide 2.4 mgWeek 0 | 5.8 | — |
| Week 26 | 4.0 | — |
| Cagrilintide 4.5 mgWeek 0 | 5.4 | — |
| Week 26 | 3.4 | — |
| Liraglutide 3.0 mgWeek 0 | 4.7 | — |
| Week 26 | 3.5 | — |
| Pooled PlaceboWeek 0 | 4.6 | — |
| Week 26 | 3.9 | — |
Change in Renin Activity
Time frame:From baseline (week 0) to week 26
change from baseline, descriptive
Posted result
| Group | Value (mean), nanograms per milliliter per hour | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 2 | — |
| Cagrilintide 0.6 mg | 0 | — |
| Cagrilintide 1.2 mg | 1 | — |
| Cagrilintide 2.4 mg | 1 | — |
| Cagrilintide 4.5 mg | 1 | — |
| Liraglutide 3.0 mg | 0 | — |
| Pooled Placebo | 0 | — |
Change in Total Cholesterol
Time frame:From baseline (week 0) to week 26
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame:From baseline (week 0) to week 26
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame:From baseline (week 0) to week 26
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame:From baseline (week 0) to week 26
VLDL, change
change from baseline, improvement
Change in Triglycerides
Time frame:From baseline (week 0) to week 26
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Change in Diastolic Blood Pressure (DBP)
Time frame:From baseline (week 0) to week 26
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change in Systolic Blood Pressure (SBP)
Time frame:From baseline (week 0) to week 26
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change in Pulse
Time frame:From baseline (week 0) to week 26
Heart rate, change
change from baseline, improvement
Change in High Sensitivity C-reactive Protein (hsCRP)
Time frame:From baseline (week 0) to week 26
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Change in Renin Activity
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Change in Aldosterone
Time frame:From baseline (week 0) to week 26
change from baseline, improvement
Safety / tolerability / PK
6 endpointsNumber of Treatment-emergent Adverse Events (TEAEs)
Time frame:From week 0 to week 32
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 335 | — |
| Cagrilintide 0.6 mg | 291 | — |
| Cagrilintide 1.2 mg | 361 | — |
| Cagrilintide 2.4 mg | 449 | — |
| Cagrilintide 4.5 mg | 460 | — |
| Liraglutide 3.0 mg | 470 | — |
| Pooled Placebo | 276 | — |
Number of Treatment-emergent Serious Adverse Events (TESAEs)
Time frame:From week 0 to week 32
Serious AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 8 | — |
| Cagrilintide 0.6 mg | 3 | — |
| Cagrilintide 1.2 mg | 8 | — |
| Cagrilintide 2.4 mg | 6 | — |
| Cagrilintide 4.5 mg | 4 | — |
| Liraglutide 3.0 mg | 4 | — |
| Pooled Placebo | 4 | — |
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
Time frame:From week 0 to week 32
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 51 | — |
| Cagrilintide 0.6 mg | 54 | — |
| Cagrilintide 1.2 mg | 52 | — |
| Cagrilintide 2.4 mg | 75 | — |
| Cagrilintide 4.5 mg | 75 | — |
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame:From week 0 to week 32
Treatment-emergent AEs (any)
event count, event
Number of Treatment-emergent Serious Adverse Events (TESAEs)
Time frame:From week 0 to week 32
Serious AEs (any)
event count, event
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
Time frame:From week 0 to week 32
Immunogenicity (ADA)
threshold achievement, event
Other (unclassified)
2 endpointsChange in Plasminogen Activator Inhibitor-1 (PAI-1) Activity
Time frame:From baseline (week 0) to week 26
change from baseline, descriptive
Change in Aldosterone
Time frame:From baseline (week 0) to week 26
change from baseline, descriptive
Posted result
| Group | Value (mean), nanograms per deciliter (ng/dL) | 95% CI |
|---|---|---|
| Cagrilintide 0.3 mg | 0.8 | — |
| Cagrilintide 0.6 mg | 0.8 | — |
| Cagrilintide 1.2 mg | 0.7 | — |
| Cagrilintide 2.4 mg | 2.2 | — |
| Cagrilintide 4.5 mg | 1.1 | — |
| Liraglutide 3.0 mg | 1.0 | — |
| Pooled Placebo | 0.5 | — |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Lancet (London, England)2021 Dec 11PMID34798060doi:10.1016/S0140-6736(21)01751-7via CT.gov reference + pubmed nct search
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.