GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 3

A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

303

Recruiting sites

Enrollment

2,500

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥35•HbA1c ≤6.5%

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 IDNCT07564414

Org study IDNN9838-7910

Secondary ID2025-522488-14European Medical Agency (EMA)

Secondary IDU1111-1323-0372World Health Organization

Timeline

Milestones

Study first posted2026-05-04actual

Study start2026-05-21actual

Last update posted2026-05-29actual

Primary completion2028-02-23estimated

Study completion2028-04-19estimated

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 (sex assigned at birth, inclusive of all gender identities).

•Age 18 years or above at the time of signing the informed consent.

•BMI≥ 35.0 kg/m^2.

•Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion criteria

•A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.

•Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

12 endpoints

Primary/protocol endpoint

Relative change in body weight

Time frame:From randomisation (week 0) to end of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From randomisation (week 0) to end of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:From randomisation (week 0) to end of treatment (week 72)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Number of participants who achieve greater than or equal to (≥) 30% weight reduction

Time frame:From randomisation (week 0) to end of treatment (week 72)

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve ≥25% weight reduction

Time frame:From randomisation (week 0) to end of treatment (week 72)

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve greater ≥ 20% weight reduction

Time frame:From randomisation (week 0) to end of treatment (week 72)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From randomisation (week 0) to end of treatment (week 72)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean change in body weight

Time frame:From randomisation (week 0) to end of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Number of participants who achieve a BMI less than (<) 30 kg/m^2

Time frame:From randomisation (week 0) to end of treatment (week 72)

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve BMI <27 kg/m^2

Time frame:end of treatment (week 72)

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2

Time frame:At end of treatment (week 72)

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve a waist-to-height ratio < 0.53

Time frame:At end of treatment (week 72)

threshold achievement, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From randomisation (week 0) to end of treatment (week 72)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants who achieve HbA1c <6.5%

Time frame:At end of treatment (week 72)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants who achieve normal HbA1c <5.7%

Time frame:At end of treatment (week 72)

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Ratio to baseline : Total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 72)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline : High density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 72)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to baseline : Low density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 72)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 72)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline : Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 72)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline: Free fatty acids

Time frame:From baseline (week 0) to end of treatment (week 72)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline : Non-HDL cholesterol

Time frame:From baseline (week 0) to end of treatment (week 72)

Non-HDL cholesterol, change

ratio, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function

Time frame:From randomisation (week 0) to end of treatment (week 72)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function

Time frame:From randomisation (week 0) to end of treatment (week 72)

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 randomisation (week 0) to end of study (week 80)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent serious adverse events (TESAEs)

Time frame:From randomisation (week 0) to end of study (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.