GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

300

actual

Study population

Obesity / overweight

Key I/E criterion

—

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 IDNCT06388187

Org study IDNN9838-7749

Secondary ID2023-509273-24European Medical Agency (EMA)

Secondary IDU1111-1298-3451World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-04-29actual

Study start2024-06-24actual

Primary completion2026-04-22actual

Study completion2026-04-22actual

Last update posted2026-05-05actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

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 above or equal to 18 years at the time of signing informed consent

1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m^2) or

2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion criteria

•Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening

•History of type 1 or type 2 diabetes

Endpoints (15)

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

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

6 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

Primary/protocol endpoint

Achievement of ≥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

Achievement of ≥10% weight reduction

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥15% weight reduction

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

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure

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

Ratio to baseline in lipids: 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

Ratio to baseline in lipids: 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

Ratio to baseline in lipids: 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

Ratio to baseline in lipids: 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

Ratio to baseline in lipids: Triglycerides

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline in lipids: Free fatty acids

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

Free fatty acids, change

ratio, 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 74)

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 (week 74)

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.