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

Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines

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. At 3 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit.

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide 2.4 mg; Drug: Placebo (semaglutide 2.4 mg)

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35365
    • Konyang University Hospital
  • Gyeonggi-Do, Korea, Republic of, 14068
    • Hallym University Sacred Heart Hospital
  • Gyeonggi-do, Korea, Republic of, 10326
    • Dongguk University Ilsan Hospital
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Hospital
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital_Bangkok
  • Bangkok, Thailand, 10700
    • Siriraj Hospital_Bangkok_1
  • Bangkok, Thailand, 10330
    • Obstetrics&Gynecology King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Division of Nutrition and Biochemical Medicine
  • Bangkok, Thailand, 10700
    • Siriraj Institute of Clinical Research
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (semaglutide 2.4 mg); Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks
Experimental: Semaglutide 2.4 mg	Drug: Semaglutide 2.4 mg; Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Percentage	From baseline (week 0) to end of treatment (week 44)
At least 5% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
At least 10% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
At least 15% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
Change in waist circumference	cm	From baseline (week 0) to end of treatment (week 44)
At least 20% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
Change in body weight	kg	From baseline (week 0) to end of treatment (week 44)
Change in body mass index	kg/m^2	From baseline (week 0) to end of treatment (week 44)
Change in systolic blood pressure	mmHg	From baseline (week 0) to end of treatment (week 44)
Change in diastolic blood pressure	mmHg	From baseline (week 0) to end of treatment (week 44)
Change in total cholesterol	mg/dL	From baseline (week 0) to end of treatment (week 44)
Change in total cholesterol	mmol/L	From baseline (week 0) to end of treatment (week 44)
Change in high-density lipoprotein (HDL) cholesterol	mg/dL	From baseline (week 0) to end of treatment (week 44)
Change in high-density lipoprotein (HDL) cholesterol	mmol/L	From baseline (week 0) to end of treatment (week 44)
Change in low-density lipoprotein (LDL) cholesterol	mg/dL	From baseline (week 0) to end of treatment (week 44)
Change in low-density lipoprotein (LDL) cholesterol	mmol/L	From baseline (week 0) to end of treatment (week 44)
Change in triglycerides	mg/dL	From baseline (week 0) to end of treatment (week 44)
Change in triglycerides	mmol/L	From baseline (week 0) to end of treatment (week 44)
Change in high-sensitivity c-reactive protein (hsCRP)	mg/L	From baseline (week 0) to end of treatment (week 44)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: NN9536-4707; U1111-1265-5285 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No