GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7.5-10%

Primary endpoint

•HbA1c, 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 IDNCT04982575

Org study IDNN9838-4862

Timeline

Milestones

Study first posted2021-07-29actual

Study start2021-08-02actual

Primary completion2022-07-07actual

Study completion2022-07-07actual

Results first posted2023-07-27actual

Last update posted2025-12-23actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Female of non-childbearing potential or male

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

•Body mass index (BMI) greater than or equal to 27.0 kg/m^2

•Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening

•Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening

•Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor

Exclusion criteria

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m^2 by central laboratory at screening

•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 (20)

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

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage of body weight	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	-14.7	—
Semaglutide 2.4 mg + Placebo (Cagrilintide)	-5.0	—

Secondary/registry result

Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	-15.4	—
Semaglutide 2.4 mg + Placebo (Cagrilintide)	-5.3	—

Secondary/protocol endpoint

Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mgChange from Baseline - in-trial	-2.2	—
Change from Baseline - on treatment without rescue	-2.2	—
Semaglutide 2.4 mg + Placebo (Cagrilintide)Change from Baseline - in-trial	-1.9	—
Change from Baseline - on treatment without rescue	-2.0	—

Treatment difference-0.3095% CI-0.79 – 0.19p0.2284Mixed Models Analysis

Primary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

Time frame:Week 0, Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage point of HbA1c	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	-2.2	—
Cagrilintide 2.4 mg + Placebo (Semaglutide)	-0.8	—

Secondary/registry result

Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	-3.4	—
Semaglutide 2.4 mg + Placebo (Cagrilintide)	-2.7	—

Secondary/registry result

CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

Time frame:Week 0, Week 32

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per liter (mmol/l)	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	-3.5	—
Cagrilintide 2.4 mg + Placebo (Semaglutide)	-1.0	—

Secondary/registry result

Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

Time frame:At week 32

CGM time-above-range

descriptive, improvement

Posted result

Group	Value (mean), Percentage of time	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	10.3	—
Cagrilintide 2.4 mg + Placebo (Semaglutide)	30.9	—

Secondary/registry result

Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

Time frame:At week 32

CGM time-in-range

descriptive, improvement

Posted result

Group	Value (mean), Percentage of time	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	88.9	—
Cagrilintide 2.4 mg + Placebo (Semaglutide)	68.9	—

Secondary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

Time frame:Week 0, Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

Time frame:Week 0, Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

Time frame:Week 0, Week 32

change from baseline, improvement

Secondary/protocol endpoint

Time frame:At week 32

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Time frame:At week 32

CGM time-in-range

descriptive, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 37

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	21	—
Cagrilintide 2.4 mg + Placebo (Semaglutide)	24	—
Semaglutide 2.4 mg + Placebo (Cagrilintide)	22	—

Secondary/registry result

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Time frame:From baseline (week 0) to week 37

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Cagrilintide 2.4 mg + Semaglutide 2.4 mg	0	—
Cagrilintide 2.4 mg + Placebo (Semaglutide)	0	—
Semaglutide 2.4 mg + Placebo (Cagrilintide)	0	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 37

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Time frame:From baseline (week 0) to week 37

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

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

Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.
Lancet (London, England)2023 Aug 26PMID37364590doi:10.1016/S0140-6736(23)01163-7via CT.gov background + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.