Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

NCT03548987 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 902

Last updated 2022-01-19

Study results available
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Summary

This study will look at the change in 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 medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection 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.

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Interventions

DRUG

Semaglutide

Subcutaneous (under the skin) injection of semaglutide once-weekly.

DRUG

Placebo

Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2020-02-22
Completion
2020-03-20
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Israel
  • Netherlands
  • Portugal
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Ukraine

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548987 on ClinicalTrials.gov