A research study to see how well CagriSema helps people with excess body weight lose weight
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2022/12/048201
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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. Male or female
3. Age above or equal to 18 years at the time of signing informed consent
4. a) BMI greater than or equal to 30.0 kg/m2 or b) BMI 27.0 kg/m2 with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease 5. History of at least one self-reported unsuccessful dietary effort to lose body weight.Extension phase 6. Randomised to treatment with either CagriSema or placebo
Glycaemia related:
1. HbA1c greater than or equal to 6.5 % (48 mmol/mol) as measured by the central laboratory at screening
2. History of type 1 or type 2 diabetes mellitusa 3. Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes mellitus or pre-diabetes within 90 days before screening
4. Treatment with a GLP-1 receptor agonist within 90 days before screening Obesity related:
5. Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
6. Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
a. Liposuction and/or abdominoplasty, if performed greater than 1 year before screening b. adjustable gastric banding, if the band has been removed greater than 1 year before screening
c. Intragastric balloon, if the balloon has been removed greater than 1 year before screening
d. Duodenal-jejunal bypass liner (e.g. Endobarrier), if the sleeve has been removed greater than 1 year before screening
7. Uncontrolled thyroid disease
8. A self-reported change in body weight greater than 5% within 90 days before screening irrespective of medical records.
9. History of major depressive disorder within 2 years before screeninga
10. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
11. A Patient Health Questionnaire-9 (PHQ-9) score of greater than or equal to 15 at screening
12. A lifetime history of a suicidal attempt
13. Suicidal behaviour within 30 days before screening
14. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 30 days before screening.
15. History or presence of chronic pancreatitisa 16. Presence of ac
ute pancreatitis within 180 days before screeninga 17. Personal or first-degree relative(s) history of multiple endocrine eoplasia type 2 or medullary thyroid carcinomaa
18. Renal impairment with estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73 m2 as measured by the central laboratory at screening
19. Presence or history of malignant neoplasms (other than basal and squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years before screeninga
20. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
21. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
22. Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator 23. Known or suspected abuse of alcohol or recreational drugs
24. Use of any medication with unknown or specified content within 90 days before screening.
25. Known or suspected hypersensitivity to Investigational Medicinal Products or related products 26. Previous participation in this study. Participation is defined as signed informed consent 27. Participation (i.e., signed informed consent) in any interventional, clinical study of an approved or non-approved investigational medicinal product within 90 days before screening
28. Other participant(s) from the same household participating in any CagriSema study 29. F
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative change in body weight <br/ ><br> & Achievement of greater than or equal to 5% weight reduction <br/ ><br>Timepoint: From baseline (week 0) to end of treatment (week 68)
- Secondary Outcome Measures
Name Time Method Achievement of greater than or equal to 20% weight reduction <br/ ><br>Timepoint: From baseline (week 0) to end of treatment (week 68) <br/ ><br>;Achievement of greater than or equal to 25% weight reduction <br/ ><br>Timepoint: From baseline (week 0) to end of treatment (week 68) <br/ ><br>;Achievement of greater than or equal to 30% weight reduction <br/ ><br>Timepoint: From baseline (week 0) to end of treatment (week 68) <br/ ><br>;Change in waist circumference <br/ ><br>Timepoint: From baseline (week 0) to end of treatment (week 68) <br/ ><br>