A Phase 2b trial of the efficacy and safety of semaglutide depot (CAM2056) in obesity or overweight

INTERVENTION: Product Name: CAM2056 10 mg/mL (semaglutide subcutaneous depot), Product Code:PRD11664053, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: CAM2056 20 mg/mL (semaglutide subcutaneous depot), Product Code:PRD11664054, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: Comparator for CAM2056 10 mg/ml and 20 mg/ml, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A CONDITION: Body weight management ; MedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861 Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: To demonstrate superiority of the CAM2056 20 mg arm compared to placebo in reduction of body weight Primary end point(s): Relative change in body weight from baseline to Week 36. Secondary Objective: To evaluate the treatment effect of the CAM2056 10 mg arm compared to placebo in reduction of body weight, To further look at the treatment effect of CAM2056 on body weight loss, To look at the treatment effect of CAM2056 on blood glucose control, To look at the treatment effect of CAM2056 on waist circumference, To look at the treatment effect of CAM2056 on blood pressure, To look at the treatment effect of CAM2056 on blood fats and free fatty acids, To evaluate the safety of CAM2056, To evaluate the treatment effect of CAM2056 20 mg compared to the CAM2056 10 mg in reduction of body weight SECONDARY OUTCOME: Secondary end point(s):Change in fasting plasma glucose from baseline to Week 12, Week 24, and Week 36. Secondary end point(s):Change in HbA1c from baseline to Week 12, Week 24, and Week 36. Secondary end point(s):Change in systolic and diastolic blood pressure from baseline to Week 12, Week 24, and Week 36 Secondary end point(s):Change in the levels of lipoprotein lipids (total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, and triglycerides) and free fatty acids from baseline to Week 36. Secondary end point(s):Change in waist circumference from baseline to Week 12, Week 24, and Week 36. Secondary end point(s):Number of participants with TEAEs during the trial Secondary end point(s):Relative change in body weight from baseline to Week 12 and Week 24. Secondary end point(s):Relative change in body weight from baseline to Week 36. Secondary end point(s):Response status at Week 12, Week 24, and Week 36, defined by relative body weight reduction from baseline of =5%, =10%, =15%, and =20%. INCLUSION CRITERIA: Man or woman, =18 years old (at the time of providing informed consent)., BMI at screening =30 kg/m2, or =27 kg/m2 to <30 kg/m2 with the presence of at least one of the following weight‐related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.