Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Drug: Semaglutide 2.4 mg; Drug: Placebo (semaglutide 2.4 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04998136

NN9536-4707

U1111-1265-5285 (Other Identifier)

Details and patient eligibility

About

This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a "dummy" medicine that looks like the study medicine, but has no effect on the body.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. 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.

Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken.

Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above or equal to 18 years at the time of signing informed consent.
• BMI at least 25.0 kg/m^2 at screening.
• Both parents of Asian descent.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

• HbA1c at least 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 above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
• Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
• Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m^2 at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Semaglutide 2.4 mg

Experimental group

Treatment:

Drug: Semaglutide 2.4 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo (semaglutide 2.4 mg)