NCT03611582|CompletedPhase 3ResultsFDA Drug

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

STEP 3

Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN9536-4375U1111-1200-8199

Study Type

interventional

Target

611

Locations

1 country

Sites

Timeline

RegisteredAug 2018

StartedAug 2018

CompletionApr 2020

Brief 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. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant 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. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.

Trial Health

On Track

Trial Health Score

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

Enrollment

611

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2018

Geographic Reach

1 country

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

1.7 years study duration

First Submitted

Initial submission to the registry

July 17, 2018

Completed

15 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 9, 2021

Completed

Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

July 17, 2018

Results QC Date

June 16, 2021

Last Update Submit

November 10, 2021

Conditions

Overweight 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 periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (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. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Baseline (week 0) to week 68
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 after 68 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 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 68 weeks

Secondary Outcomes (29)

Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
After 68 weeks
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
After 68 weeks
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
After 68 weeks
Change in Waist Circumference
Baseline (week 0) to week 68
Change in Systolic Blood Pressure
Baseline (week 0) to week 68
+24 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

Participants will receive semaglutide 2.4 mg during 68-week treatment period in addition to intensive behavioural therapy.

Drug: Semaglutide

Semaglutide placebo

PLACEBO COMPARATOR

Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.

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.

Semaglutide placebo

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
Body mass index 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:

Hemoglobin A1c 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.