Brief Summary

This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

957

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2015

Geographic Reach

8 countries

74 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

1.5 years study duration

First Submitted

Initial submission to the registry

May 21, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed

13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed

3 years until next milestone

Results Posted

Study results publicly available

April 17, 2020

Completed

Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

May 21, 2015

Results QC Date

March 18, 2020

Last Update Submit

April 14, 2020

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (1)

Relative Change in Body Weight (%)
Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Week 0, Week 52

Secondary Outcomes (36)

Participants With Weight Loss of ≥5% of Baseline Body Weight
Week 52
Participants With Weight Loss of ≥10% of Baseline Body Weight
Week 52
Change in Body Weight (kg)
Week 0, Week 52
Change in Waist Circumference
Week 0, Week 52
Change in Waist to Hip Circumference Ratio
Week 0, Week 52
+31 more secondary outcomes

Study Arms (16)

Sema 0.05 mg

EXPERIMENTAL

Dose 0.05 mg

Drug: semaglutide

Sema 0.1 mg

EXPERIMENTAL

Dose 0.05 or 0.1 mg with dose escalation every fourth week

Drug: semaglutide

Sema 0.2 mg

EXPERIMENTAL

Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week

Drug: semaglutide

Sema 0.3 mg

EXPERIMENTAL

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week

Drug: semaglutide

Sema 0.4 mg

EXPERIMENTAL

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week

Drug: semaglutide

Sema 0.3 mg (fast dose escalation)

EXPERIMENTAL

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week

Drug: semaglutide

Sema 0.4 mg (fast dose escalation)

EXPERIMENTAL

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week

Drug: semaglutide

Lira 3.0 mg

ACTIVE COMPARATOR

Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week

Drug: liraglutide

Placebo Sema 0.05 mg

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.05 mg

Drug: placebo

Placebo Sema 0.1 mg

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.1 mg

Drug: placebo

Placebo Sema 0.2 mg

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.2 mg

Drug: placebo

Placebo Sema 0.3 mg

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.3 mg

Drug: placebo

Placebo Sema 0.4 mg

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.4 mg

Drug: placebo

Placebo Sema 0.3 mg (fast dose escalation)

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)

Drug: placebo

Placebo Sema 0.4 mg (fast dose escalation)

PLACEBO COMPARATOR

Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)

Drug: placebo

Placebo Lira 3.0 mg

PLACEBO COMPARATOR

Placebo arm matching active arm Lira 3.0 mg

Drug: placebo

Interventions

semaglutideDRUG

Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Sema 0.05 mgSema 0.1 mgSema 0.2 mgSema 0.3 mgSema 0.3 mg (fast dose escalation)Sema 0.4 mgSema 0.4 mg (fast dose escalation)

liraglutideDRUG

Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Lira 3.0 mg

placeboDRUG

Once-daily subcutaneous (s.c., under the skin) administration.

Placebo Lira 3.0 mgPlacebo Sema 0.05 mgPlacebo Sema 0.1 mgPlacebo Sema 0.2 mgPlacebo Sema 0.3 mgPlacebo Sema 0.3 mg (fast dose escalation)Placebo Sema 0.4 mgPlacebo Sema 0.4 mg (fast dose escalation)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.