DelfaGLP-1 Atlas

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CompletedPhase 3

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

Efficacy and Safety of Cagrilintide S.C. 2.4 mg in Combination With Semaglutide S.C. 2.4 mg (CagriSema S.C. 2.4 mg/2.4 mg) Once-Weekly in East Asian Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

28

Recruiting sites

—

Enrollment

331

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥27•HbA1c 7-10%

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

NCT IDNCT05813925
Org study IDNN9838-4762
Secondary IDjRCT2031220734jRCT (Japan)
Secondary IDU1111-1277-3764World Health Organization (WHO)

Timeline

Milestones

Study start2023-04-03actual
Study first posted2023-04-14actual
Primary completion2025-01-17actual
Study completion2025-03-07actual
Last update posted2026-01-22actual

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female
•Age greater than to or equal 18 years at the time of signing informed consent
a)Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or
b)BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D

Diabetes-related for participant with T2D

•Diagnosed with T2D greater than or equal to 180 days before screening
•HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening
•Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors [AGI], glinides, sodium-glucose cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] as a single agent or in combination) according to local label
•Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

Exclusion criteria

Obesity-related

- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening

Glycaemia-related for participant without T2D

•HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
•History of type 1 or type 2 diabetes

Diabetes-related for participant with T2D

•Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2) as measured by central laboratory at screening
•Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Endpoints (26)

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
12
Cardiometabolic biomarkers
8
Glycemic / diabetes
3
Safety / tolerability / PK
2
Patient-reported / QoL
1

Weight & body composition

12 endpoints
Primary/protocol endpoint

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

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

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

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population

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

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in VFA Measured by CT Scan in Subset of the Japanese Study Population

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

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)

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

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent

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

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

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

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

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

Change in Body Mass Index (BMI)

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

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

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

Change in Fasting Plasma Glucose (FPG)

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

Change in Fasting Insulin

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

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

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

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

Change in Total Cholesterol

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

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High-Density Lipoprotein (HDL) Cholesterol

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

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low-Density Lipoprotein (LDL) Cholesterol

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

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low-Density Lipoprotein (VLDL)

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

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Triglycerides

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

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Free fatty Acids

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

Free fatty acids, change

percent change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

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 end of treatment (week 68)

IWQOL-Lite physical

change from baseline, 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 (week 75)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

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

Serious AEs (any)

event count, event

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

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.