Weight loss in people living with overweight or obesity and type 2 diabetes following treatment with cagrilintide

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

31 Oct 2025 → ongoing

Decision date (initial)

2025-11-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-519531-41-00

WHO UTN

U1111-1314-9328

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To confirm superiority on body weight reduction of cagrilintide s.c. 00 mg once weekly versus placebo, as adjunct to lifestyle intervention counselling, in participants with overweight or obesity, and type 2 diabetes.
To confirm superiority of cagrilintide 00 mg versus placebo on achievement of ≥ 5% weight reduction.

Secondary objectives 9

1. To confirm superiority of cagrilintide 00 mg versus placebo on achievement of: ≥ 10% weight reduction ≥ 15% weight reduction
2. To confirm superiority of cagrilintide s.c. 00 mg once weekly versus placebo on: Waist circumference Triglycerides High-sensitivity C-reactive protein (hsCRP) Physical functioning
3. To compare the effect of cagrilintide s.c. 00 mg once weekly versus placebo on body weight
4. To compare the effect of cagrilintide s.c. 00 mg once weekly versus placebo on: Health-related quality of life Weight-related quality of life
5. To compare the effect of cagrilintide s.c. 00 mg once weekly versus placebo on likelihood of achieving clinically relevant improvement in physical functioning.
6. To compare the effect of cagrilintide s.c. 00 mg once weekly versus placebo on blood pressure.
7. To compare the effect of cagrilintide s.c. 00 mg once weekly versus placebo on lipids.
8. To compare the effect of cagrilintide s.c. 00 mg once weekly versus placebo on glycaemic measures.
9. To compare the safety and tolerability of cagrilintide s.c. 00 mg once weekly versus placebo.

Conditions and MedDRA coding

Overweight and obesity

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Female or male (sex at birth).
3. Age 18 years or above at the time of signing the informed consent.
4. History of at least one self-reported unsuccessful dietary effort to lose body weight.
5. Body mass index (BMI) ≥ 27.0 kg/m2.
6. Diagnosed with type 2 diabetes ≥ 180 days before screening.
7. Treatment with either lifestyle intervention, or: a. Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice. b. For up to 30% of participants the following concomitant medication is allowed: i. Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening and/or ii. Treatment with basal insulin minimum (0.25 U/kg/day or 20 U/day) stable for at least 90 days before screening.

Exclusion criteria 3

1. Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
2. Previous dosing of marketed or non-marketed amylin-based compounds.
3. Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomised according to inclusion criteria 7bi.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Relative change in body weight.
2. Achievement of ≥ 5% body weight reduction.

Secondary endpoints 21

1. Achievement of ≥ 10% body weight reduction.
2. Achievement of ≥ 15% body weight reduction.
3. Change in waist circumference.
4. Ratio to baseline in triglycerides.
5. Ratio to baseline in hsCRP.
6. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score.
7. Change in body weight.
8. Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score.
9. Change in SF-36v2® mental component summary score.
10. Change in IWQOL-Lite-CT total score.
11. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score.
12. Change in systolic blood pressure.
13. Change in diastolic blood pressure.
14. Ratio to baseline of: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Free fatty acids CCI CCI
15. Change in glycated haemoglobin (HbA1c).
16. Change in fasting plasma glucose.
17. Ratio to baseline in fasting serum insulin.
18. Number of treatment emergent adverse events.
19. Number of treatment emergent serious adverse events.
20. Number of clinically significant hypoglycaemic episodes (level 2): <3.0 mmol/L [54 mg/dL], confirmed by BG meter
21. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 7

Locations

5 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications