At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓BMI ≥30 kg/m²
- ✓Type 2 diabetes diagnosed ≥180 days before screening
- ✓HbA1c between 7.0% and 10.0% (53-86 mmol/mol)
- ✕Weight change >5 kg within 90 days before screening
- ✕Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- ✕Renal impairment: eGFR <30 mL/min/1.73 m² (or <45 mL/min/1.73 m² if on SGLT2 inhibitors)
- ✕Uncontrolled or potentially unstable diabetic retinopathy or maculopathy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Semaglutide and Placebo for Obesity and Diabetes Mellitus, Type 2. Completed, enrolled 512 participants across 76 sites in 8 countries.
Detailed Summary
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
Study Details
Timeline
Interventions
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.