A research study to look into the long-term effect on weight loss of CagriSema in people with obesity

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

22 Jan 2025 → ongoing

Decision date (initial)

2025-01-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-512144-39-00

WHO UTN

U1111-1304-7430

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To confirm superiority of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly, as an adjunct to a reduced calorie diet and increased physical activity, on body weight reduction in participants with obesity

Secondary objectives 12

1. To confirm superiority of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly, as an adjunct to a reduced calorie diet and increased physical activity, on cardiometabolic parameters in participants with obesity with respect to: - Waist circumference - Waist to height ratio - Systolic blood pressure (SBP)
2. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on lipids in participants with obesity
3. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on BMI in participants with obesity
4. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on glucose metabolism in participants with obesity
5. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on glycaemic control and other cardiovascular risk factors in participants with obesity
6. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on improvement of pre existing obesity-related complications (ORCs) in participants with obesity
7. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on inflammation in participants with obesity
8. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on body composition in participants with obesity
9. To compare the effect of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly on clinical outcome assessments (physical functioning, weight-related functioning, limitations in daily activities due to excess weight, and control of eating) in participants with obesity
10. To compare the safety and tolerability of CagriSema s.c. 0.0 mg/0.0 mg versus placebo once weekly in participants with obesity
11. To compare the safety and tolerability of CagriSema s.c. 0.0 mg/0.0 mg versus CagriSema s.c. dose tapering algorithm once weekly in participants with obesity
12. To investigate the safety and tolerability of CagriSema 0.0 mg/0.0 mg once weekly according to a flexible escalation regime in participants with obesity (former placebo group)

Conditions and MedDRA coding

Obesity

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Male or female
2. Age above or equal to 18 years at the time of signed informed consent
3. BMI ≥35.0 kg/m2

Exclusion criteria 2

1. HbA1c≥6.5% (48 mmol/mol) as measured by the central laboratory at screening
2. History of type 1 or type 2 diabetes

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relative change in body weight

Secondary endpoints 30

1. Achievement of ≥ 20% body weight reduction (yes/no)
2. Achievement of ≥ 25% body weight reduction (yes/no)
3. Achievement of ≥ 30% body weight reduction (yes/no)
4. Change in waist circumference
5. Change in waist to height ratio
6. Change in SBP
7. Ratio to baseline in: • Total cholesterol • High density lipoprotein (HDL) cholesterol • Low density lipoprotein (LDL) cholesterol • Very low-density lipoprotein (VLDL) cholesterol • Triglycerides • Free fatty acids • Non-HDL cholesterol
8. Change in BMI
9. Achievement of BMI < 30 kg/m2
10. Change in glycated haemoglobin (HbA1c)
11. Change in Fasting Plasma Glucose (FPG)
12. Achievement of HbA1c < 5.7% and FPG < 100 mg/dL with prediabetes at baseline
13. Time to HbA1c < 5.7% and FPG < 100 mg/dL with prediabetes at baseline
14. Development of HbA1c ≥ 5.7% or FPG > 100 mg/dL with normoglycemia at baseline
15. Development of T2D as per ADA guideline
16. Time to T2D diagnosis as per ADA guideline
17. Change in ACC/AHA 10-year ASCVD risk score
18. Improvement in ≥ 1 pre existing cardiometabolic ORC (hypertension, prediabetes, or dyslipidaemia)
19. Ratio to baseline in C-reactive protein (CRP)
20. Change in total fat mass by dual energy X-ray absorption (DXA) absolute and relative to total body mass
21. Change in visceral fat mass by DXA, relative to baseline and relative to total amount of fat mass in visceral fat mass region
22. Change in lean body mass by DXA absolute and relative to total body mass
23. Change in SF-36 Physical functioning score
24. Change in IWQOL-Lite-CT: • Physical function score • Physical score • Psychosocial score • Total score
25. Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score
26. Change in Control of Eating questionnaire (CoEQ): • Craving Control score • Positive Mood score • Craving for Sweets score • Craving for Savoury score • Hunger score • Satiety score
27. Number of Treatment Emergent Adverse Events (TEAEs)
28. Number of Treatment Emergent Serious Adverse Events (TESAEs)
29. Achievement of HbA1c ≥ 6.5% or FPG ≥ 126 mg/dL with prediabetes at baseline
30. Time to HbA1c ≥ 6.5% or FPG ≥ 126 mg/dL with prediabetes at baseline

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 10

Locations

3 EU/EEA countries · 14 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 30 files

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

Application history

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