Brief Summary

This study will look at the change in participants' 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, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.

Trial Health

On Track

Trial Health Score

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

Enrollment

401

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jan 2019

Geographic Reach

2 countries

28 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

1.8 years study duration

First Submitted

Initial submission to the registry

January 18, 2019

Completed

3 days until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

March 22, 2022

Completed

Last Updated

March 22, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

January 18, 2019

Results QC Date

November 17, 2021

Last Update Submit

February 23, 2022

Conditions

Overweight Obesity

Outcome Measures

Primary Outcomes (2)

Change in Body Weight (%)
Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Baseline (week 0), week 68
Number of Participants Who Achieve (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 week 68 for in-trial observation period 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. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
At week 68

Secondary Outcomes (37)

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
At week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
At week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
At week 68
Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest
Baseline (week 0) to week 68
Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
Baseline (week 0) to week 68
+32 more secondary outcomes

Study Arms (4)

Semaglutide 2.4 mg

EXPERIMENTAL

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.

Drug: Semaglutide

Placebo (semaglutide 2.4 mg)

PLACEBO COMPARATOR

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.

Drug: Placebo (semaglutide)

Semaglutide 1.7 mg

EXPERIMENTAL

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.

Drug: Semaglutide

Placebo (semaglutide 1.7 mg)

PLACEBO COMPARATOR

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.

Drug: Placebo (semaglutide)

Interventions

SemaglutideDRUG

Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.

Semaglutide 1.7 mgSemaglutide 2.4 mg

Placebo (semaglutide)DRUG

Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.

Placebo (semaglutide 1.7 mg)Placebo (semaglutide 2.4 mg)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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
BMI more than or equal to 27.0 kg/m\^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m\^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
History of at least one self-reported unsuccessful dietary effort to lose body weight
For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

You may not qualify if:

A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 mL/min/1.73 m\^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

Contact the study team to confirm eligibility.