NCT04074161|CompletedPhase 3ResultsFDA Drug

Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

STEP 8

Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN9536-4576U1111-1233-0977

Study Type

interventional

Target

338

Locations

1 country

Sites

Timeline

RegisteredAug 2019

StartedSep 2019

CompletionMay 2021

Brief Summary

This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Trial Health

On Track

Trial Health Score

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

Enrollment

338

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2019

Geographic Reach

1 country

19 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

August 28, 2019

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed

13 days until next milestone

Study Start

First participant enrolled

September 11, 2019

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2021

Completed

12 months until next milestone

Results Posted

Study results publicly available

April 27, 2022

Completed

Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

August 28, 2019

Results QC Date

March 21, 2022

Last Update Submit

May 18, 2023

Conditions

Overweight Obesity

Outcome Measures

Primary Outcomes (1)

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)
Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Baseline (week 0), week 68

Secondary Outcomes (31)

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)
From baseline (week 0) to week 68
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)
From baseline (week 0) to week 68
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)
From baseline (week 0) to week 68
Change From Baseline (Week 0) to Week 68 in Waist Circumference
Baseline (week 0), week 68
Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))
Baseline (week 0), week 68
+26 more secondary outcomes

Study Arms (4)

Semaglutide

EXPERIMENTAL

Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity

Drug: Semaglutide

Placebo (semaglutide)

PLACEBO COMPARATOR

Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity

Drug: Placebo (semaglutide)

Liraglutide

ACTIVE COMPARATOR

Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity

Drug: Liraglutide

Placebo (liraglutide)

PLACEBO COMPARATOR

Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity

Drug: Placebo (liraglutide)

Interventions

SemaglutideDRUG

Dose gradually increased to 2.4 mg administered once weekly for 68 weeks

Semaglutide

Placebo (semaglutide)DRUG

Administered once weekly for 68 weeks

Placebo (semaglutide)

LiraglutideDRUG

Dose gradually increased to 3.0 mg administered once daily for 68 weeks

Liraglutide

Placebo (liraglutide)DRUG

Administered once daily for 68 weeks

Placebo (liraglutide)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age 18 years or older at the time of signing informed consent
Body mass index (BMI) equal to or above 30.0 kg/m\^2 or equal to or above 27.0 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:

HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
History of type 1 or type 2 diabetes mellitus
A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Contact the study team to confirm eligibility.