DelfaGLP-1 Atlas

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Active not recruitingPhase 3

A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

46

Recruiting sites

—

Enrollment

609

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

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 IDNCT07011667
Org study IDNN9838-8484
Secondary IDU1111-1318-6372World Health Organization (WHO)

Timeline

Milestones

Study start2025-06-03actual
Study first posted2025-06-09actual
Last update posted2025-12-12actual
Primary completion2027-03-01estimated
Study completion2028-10-17estimated

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

key Inclusion Criteria:

•Male or female (sex at birth).
•Age 18 years or above at the time of signing the informed consent.
•BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening.
•Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.

key Exclusion Criteria:

•Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening.
•History of type 1 or type 2 diabetes.

Endpoints (40)

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

Patient-reported / QoL
15
Weight & body composition
13
Cardiometabolic biomarkers
10
Safety / tolerability / PK
2

Weight & body composition

13 endpoints
Primary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to week 80

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of participants who achieve greater than or equals (≥) 20% weight reduction

Time frame:From baseline (week 0) to week 80

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve ≥ 25% weight reduction

Time frame:From baseline (week 0) to week 80

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve ≥ 30% weight reduction

Time frame:From baseline (week 0) to week 80

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)

Time frame:From baseline (week 0) to week 80

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve BMI < 30 kg/m^2

Time frame:From baseline (week 0) to week 80

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to week 80

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Number of participants who achieve ≥ 5% weight reduction

Time frame:From baseline (week 0) to week 80

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve ≥ 10% weight reduction

Time frame:From baseline (week 0) to week 80

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve ≥ 15% weight reduction

Time frame:From baseline (week 0) to week 80

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist to height ratio

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in waist to hip ratio

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Number of participants with reduction in weight category

Time frame:From baseline (week 0) to week 80

threshold achievement, improvement

Cardiometabolic biomarkers

10 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From baseline (week 0) to week 80

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Ratio to baseline in C-reactive protein (CRP)

Time frame:From baseline (week 0) to week 80

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to week 80

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: triglycerides

Time frame:From baseline (week 0) to week 80

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline in lipids: HDL

Time frame:From baseline (week 0) to week 80

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From baseline (week 0) to week 80

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to baseline in lipids: total cholesterol

Time frame:From baseline (week 0) to week 80

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to week 80

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to week 80

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: free fatty acids

Time frame:From baseline (week 0) to week 80

Free fatty acids, change

ratio, improvement

Patient-reported / QoL

15 endpoints
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 week 80

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in short form (SF)-36v2 physical function

Time frame:From baseline (week 0) to week 80

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])

Time frame:From baseline (week 0) to week 80

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)

Time frame:From baseline (week 0) to week 80

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in control of eating questionnaire (CoEQ): craving control score

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ: positive mood score

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ: craving for sweets score

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ: craving for savoury score

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ: hunger score

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in CoEQ: satiety score

Time frame:From baseline (week 0) to week 80

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: physical score

Time frame:From baseline (week 0) to week 80

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: psychosocial score

Time frame:From baseline (week 0) to week 80

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: total score

Time frame:From baseline (week 0) to week 80

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 health survey acute: physical component summary score

Time frame:From baseline (week 0) to week 80

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 health survey acute: mental component summary

Time frame:From baseline (week 0) to week 80

SF-36 mental

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 week 80

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 week 80

Serious AEs (any)

event count, event

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.