A research study to see how well CagriSema helps people with type 2 diabetes and excess body weight lose weight

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

30 Jan 2023 → 3 Feb 2025

Decision date (initial)

2024-08-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2023-506931-13-00

EudraCT number

2021-005121-24

WHO UTN

U1111-1267-4287

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To confirm superiority on body weight reduction of CagriSema versus placebo as adjunct to reduced-calorie
diet and increased physical activity in participants with overweight or obesity and T2D.

Secondary objectives 2

1. To confirm superiority of CagriSema versus placebo on: Achievement of ≥ 20% weight reduction Weight loss week 20 Waist circumference Glycated Haemoglobin Systolic blood pressure Physical functioning
2. To compare the safety and tolerability of CagriSema versus placebo.

Conditions and MedDRA coding

Overweight and obesity and type 2 diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male or female
2. Age above or equal to 18 years at the time of signing informed consent
3. BMI ≥ 27.0 kg/m2
4. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening
5. Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
6. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
7. HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Exclusion criteria 3

1. Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
2. Renal impairment with estimated glomerular filtration rate (eGFR)< 30 mL/min/1.73 m2, as measured by the central laboratory at screening
3. 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

Primary and secondary outcome measures (English text)

Primary endpoints 2

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

Secondary endpoints 11

1. Achievement of ≥ 20% weight reduction
2. Relative change in body weight
3. Change in waist circumference
4. Change in Glycated Haemoglobin (HbA1c)
5. Change in Systolic Blood Pressure (SBP)
6. Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
7. Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score
8. Number of Treatment Emergent Adverse Events (TEAEs)
9. Number of Treatment Emergent Serious adverse events (TESAEs)
10. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
11. 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 5

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 13

Locations

5 EU/EEA countries · 40 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 44 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