A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Semaglutide Subcutaneous Depot (CAM2056) in People with Obesity or Overweight

Conditions

Body weight management

Brief summary

Relative change in body weight from baseline to Week 36.

Detailed description

Relative change in body weight from baseline to Week 36., Relative change in body weight from baseline to Week 12 and Week 24., Response status at Week 12, Week 24, and Week 36, defined by relative body weight reduction from baseline of ≥5%, ≥10%, ≥15%, and ≥20%., Change in HbA1c from baseline to Week 12, Week 24, and Week 36., Change in fasting plasma glucose from baseline to Week 12, Week 24, and Week 36., Change in waist circumference from baseline to Week 12, Week 24, and Week 36., Change in systolic and diastolic blood pressure from baseline to Week 12, Week 24, and Week 36, 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., Number of participants with TEAEs during the trial

Related papers

No related papers found yet.

Interventions

DRUGCAM2056 10 mg/mL (semaglutide subcutaneous depot)

DRUGCAM2056 20 mg/mL (semaglutide subcutaneous depot)

DRUGComparator for CAM2056 10 mg/ml and 20 mg/ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relative change in body weight from baseline to Week 36.	—

Secondary

Measure	Time frame
Relative change in body weight from baseline to Week 36., Relative change in body weight from baseline to Week 12 and Week 24., Response status at Week 12, Week 24, and Week 36, defined by relative body weight reduction from baseline of ≥5%, ≥10%, ≥15%, and ≥20%., Change in HbA1c from baseline to Week 12, Week 24, and Week 36., Change in fasting plasma glucose from baseline to Week 12, Week 24, and Week 36., Change in waist circumference from baseline to Week 12, Week 24, and Week 36., Change in systolic and diastolic blood pressure from baseline to Week 12, Week 24, and Week 36, 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., Number of participants with TEAEs during the trial	—

Measure

Time frame

Relative change in body weight from baseline to Week 36., Relative change in body weight from baseline to Week 12 and Week 24., Response status at Week 12, Week 24, and Week 36, defined by relative body weight reduction from baseline of ≥5%, ≥10%, ≥15%, and ≥20%., Change in HbA1c from baseline to Week 12, Week 24, and Week 36., Change in fasting plasma glucose from baseline to Week 12, Week 24, and Week 36., Change in waist circumference from baseline to Week 12, Week 24, and Week 36., Change in systolic and diastolic blood pressure from baseline to Week 12, Week 24, and Week 36, 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., Number of participants with TEAEs during the trial

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Outcome results

None listed