NCT03548987|CompletedPhase 3ResultsFDA Drug

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 4

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9536-4376U1111-1201-08982017-003473-34

Study Type

interventional

Target

902

Locations

10 countries

Sites

Timeline

RegisteredJun 2018

StartedJun 2018

CompletionMar 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. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The 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 1.5 years.

Trial Health

On Track

Trial Health Score

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

Enrollment

902

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2018

Geographic Reach

10 countries

72 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

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

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2020

Completed

27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed

12 months until next milestone

Results Posted

Study results publicly available

March 15, 2021

Completed

Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

May 25, 2018

Results QC Date

February 19, 2021

Last Update Submit

January 7, 2022

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (1)

Change From Randomisation to Week 68 in Body Weight (%)
Change in body weight from baseline (week 20) 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 start of run-in (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).
Randomisation (week 20) to week 68

Secondary Outcomes (36)

Change in Waist Circumference
Randomization (week 20) to week 68
Change in Systolic Blood Pressure
Randomization (week 20) to week 68
Change in Diastolic Blood Pressure
Randomization (week 20) to week 68
Change in Physical Functioning Score (Short Form 36 [SF-36])
Randomization (week 20) to week 68
Change in Body Weight [Kilogram (Kg)]
Randomisation (week 20) to week 68
+31 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks. Maintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68). The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks. Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68). The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Drug: SemaglutideDrug: Placebo

Interventions

SemaglutideDRUG

Subcutaneous (under the skin) injection of semaglutide once-weekly.

PlaceboSemaglutide

PlaceboDRUG

Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 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

You may not qualify if:

Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by 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.