Brief Summary

This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. 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 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

304

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Oct 2018

Geographic Reach

5 countries

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

October 1, 2018

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed

2 days until next milestone

Study Start

First participant enrolled

October 5, 2018

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed

1 year until next milestone

Results Posted

Study results publicly available

March 23, 2022

Completed

Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

October 1, 2018

Results QC Date

February 2, 2022

Last Update Submit

July 5, 2023

Conditions

Overweight Obesity

Outcome Measures

Primary Outcomes (2)

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight
Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
From Baseline (Week 0) to Week 104
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
Number of participants who achieved greater than or equal to (\>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>=5% weight loss, whereas 'No' infers the number of participants who have not achieved \>=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
At Week 104

Secondary Outcomes (35)

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
At Week 104
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
At Week 104
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
At Week 104
Change From Baseline (Week 0) to Week 104 in Waist Circumference
From Baseline (Week 0) to Week 104
Change From Baseline (Week 0) to Week 104 in Body Weight (kg)
From Baseline (Week 0) to Week 104
+30 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Drug: Placebo (Semaglutide)

Interventions

SemaglutideDRUG

Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Semaglutide

Placebo (Semaglutide)DRUG

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

Placebo

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age more than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
History of at least one self-reported unsuccessful dietary effort to lose body weight

You may not qualify if:

HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Contact the study team to confirm eligibility.