CTRI/2022/12/048201Active, not recruitingPhase 3
Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (Cagrisema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity. NN9838-4608(Redefine 1)
ovo Nordisk AS0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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