Brief Summary

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,961

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2018

Typical duration for phase_3

Geographic Reach

17 countries

128 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

May 25, 2018

Completed

10 days until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed

5 months until next milestone

Results Posted

Study results publicly available

August 11, 2021

Completed

Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

May 25, 2018

Results QC Date

June 16, 2021

Last Update Submit

November 18, 2021

Conditions

Metabolism and Nutrition Disorder Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

Change in Body Weight (%)
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Baseline (week 0) to week 68
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)
Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.
After week 68

Secondary Outcomes (40)

Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)
Week 68
Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)
Week 68
Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)
Week 68
Change in Waist Circumference (cm)
Baseline (week 0) to week 68
Change in Systolic Blood Pressure (mmHg)
Baseline (week 0) to week 68
+35 more secondary outcomes

Study Arms (2)

Semaglutide s.c. 2.4 mg once weekly

EXPERIMENTAL

Participants will receive semaglutide for 68 weeks.

Drug: Semaglutide

Semaglutide placebo

PLACEBO COMPARATOR

Participants will receive semaglutide matching placebo for 68 weeks.

Drug: Placebo (semaglutide)

Interventions

SemaglutideDRUG

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.

Semaglutide s.c. 2.4 mg once weekly

Placebo (semaglutide)DRUG

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.

Semaglutide placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Main phase:
Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm 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
Extension phase:
Informed consent for the extension phase obtained before any trial related activities for the extension phase
On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo

You may not qualify if:

Main phase:
Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Extension phase:
Female who is pregnant or intends to become pregnant during the extension phase

Contact the study team to confirm eligibility.