Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

NCT03552757 · Completed

Last updated 2026-05-28

This clinical trial is testing how well the medication semaglutide at a 2.4 mg dose reduces body weight in adults with type 2 diabetes who also have overweight or obesity.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 1,210 people

Who can join Ages 18+ · all sexes

Timeline Started 2018-06 · est. completion 2020-05

Where 147 sites · Argentina, Canada, Germany, Greece, India, Japan, Puerto Rico, Russia, South Africa, Spain, United Arab Emirates, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT03552757 ↗

Description as written by the study sponsor.

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

Treatments tested

Semaglutide 1.0 mg Drug

Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Semaglutide 2.4 mg Drug

Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Placebo I (Semaglutide) Drug

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Placebo II (Semaglutide) Drug

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Main thing measured	Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo
Sponsor	Novo Nordisk A/S
Conditions studied	Obesity, Overweight
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03552757 ↗