DelfaGLP-1 Atlas

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Active not recruitingPhase 3

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

254

Recruiting sites

—

Enrollment

3,400

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

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

NCT IDNCT05567796
Org study IDNN9838-4608
Secondary ID2020-005435-75
Secondary IDUniversal Trial Number (UTN)U1111-1261-1912

Timeline

Milestones

Study first posted2022-10-05actual
Study start2022-11-01actual
Primary completion2024-10-30actual
Last update posted2026-05-05actual
Study completion2026-10-19estimated

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female
•Age above or equal to 18 years at the time of signing informed consent
•Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion criteria

- Glycaemia related:

a)Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
b)History of type 1 or type 2 diabetes mellitus

Endpoints (67)

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
29
Cardiometabolic biomarkers
16
Patient-reported / QoL
15
Glycemic / diabetes
5
Safety / tolerability / PK
2

Weight & body composition

29 endpoints
Primary/protocol endpoint

CagriSema versus placebo: Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction

Time frame:From baseline (week 0) to end of treatment (week 68)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Achievement of >= 20% weight reduction

Time frame:From baseline (week 0) to end of treatment (week 68)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Achievement of >= 25% weight reduction

Time frame:From baseline (week 0) to end of treatment (week 68)

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Achievement of >= 30% weight reduction

Time frame:From baseline (week 0) to end of treatment (week 68)

threshold achievement, improvement

Secondary/protocol endpoint

CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Relative change in body weight

Time frame:From baseline (week 0) to week 8

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Relative change in body weight

Time frame:From baseline (week 0) to week 20

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 68)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)

Time frame:From baseline (week 0) to end of treatment (week 68)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category

Time frame:From baseline (week 0) to end of treatment (week 68)

categorical status, improvement

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 68)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Relative change in body weight (Measured in kilograms (kg))

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Relative change in body weight (Measured in percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Absolute change in body weight (Measured in kilograms (kg))

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Absolute change in body weight (Measured in percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg))

Time frame:From baseline (week 0) to end of treatment (week 68)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg))

Time frame:From baseline (week 0) to end of treatment (week 68)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)

Time frame:From baseline (week 0) to end of treatment (week 68)

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points)

Time frame:From baseline (week 0) to end of treatment (week 68)

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))

Time frame:From baseline (week 0) to end of treatment (week 68)

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))

Time frame:From baseline (week 0) to end of treatment (week 68)

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))

Time frame:From baseline (week 0) to end of treatment (week 68)

Lean mass

percent change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 68)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

CagriSema versus placebo: Change in HbA1c

Time frame:From baseline (week 0) to end of treatment (week 68)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).

Time frame:From baseline (week 0) to end of treatment (week 68)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

CagriSema versus placebo: Change in FPG (mg/dL)

Time frame:From baseline (week 0) to end of treatment (week 68)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in fasting serum insulin

Time frame:From baseline (week 0) to end of treatment (week 68)

ratio, improvement

Cardiometabolic biomarkers

16 endpoints
Secondary/protocol endpoint

CagriSema versus placebo: Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to end of treatment (week 68)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)

Time frame:From baseline (week 0) to end of treatment (week 68)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 68)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 68)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 68)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 68)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 68)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

CagriSema versus placebo: Ratio to baseline in Free fatty acids

Time frame:From baseline (week 0) to end of treatment (week 68)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Change in SBP

Time frame:From baseline (week 0) to end of treatment (week 68)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Ratio to baseline in total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 68)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Ratio to baseline in HDL

Time frame:From baseline (week 0) to end of treatment (week 68)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Ratio to baseline in LDL

Time frame:From baseline (week 0) to end of treatment (week 68)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Ratio to baseline in VLDL

Time frame:From baseline (week 0) to end of treatment (week 68)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 68)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Free fatty acids

Time frame:From baseline (week 0) to end of treatment (week 68)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

CagriSema versus placebo, semalutide and cagrilintide: Ratio to baseline C-reactive protein (CRP)

Time frame:From baseline (week 0) to end of treatment (week 68)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Patient-reported / QoL

15 endpoints
Secondary/protocol endpoint

CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score

Time frame:From baseline (week 0) to end of treatment (week 68)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score

Time frame:From baseline (week 0) to end of treatment (week 68)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score

Time frame:From baseline (week 0) to end of treatment (week 68)

IWQOL-Lite physical

threshold achievement, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score

Time frame:From baseline (week 0) to end of treatment (week 68)

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in IWQOL-Lite-CT - Physical Function Score

Time frame:From baseline (week 0) to end of treatment (week 68)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo: Change in IWQOL-Lite-CT - Total Score

Time frame:From baseline (week 0) to end of treatment (week 68)

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in Control of Eating (COEQ): Craving Control Score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Craving for Savoury food score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Hunger score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Craving for Sweets Score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Positive Mood score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

Change in COEQ: Satiety score

Time frame:From baseline (week 0) to end of treatment (week 68)

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score

Time frame:From baseline (week 0) to end of treatment (week 68)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

Time frame:From baseline (week 0) to end of treatment (week 68)

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study-main part (week 75)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Serious adverse events (TESAEs)

Time frame:From baseline (week 0) to end of study-main part (week 75)

Serious AEs (any)

event count, event

Publications (2)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.