Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (STEP 8)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo (semaglutide); Drug: Liraglutide; Drug: Semaglutide; Drug: Placebo (liraglutide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04074161

NN9536-4576

U1111-1233-0977 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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338 participants in 4 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

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

Treatment:

Drug: Semaglutide

Placebo (semaglutide)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (semaglutide)

Liraglutide

Active Comparator group

Description:

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

Treatment:

Drug: Liraglutide

Placebo (liraglutide)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (liraglutide)