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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998136
• Other study ID #: NN9536-4707
• Secondary ID: U1111-1265-5285
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 20, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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
• Placebo (semaglutide 2.4 mg)
Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks

Locations

Country	Name	City	State
Korea, Republic of	Konyang university hospital	Daejeon
Korea, Republic of	Dongguk University Ilsan Hospital	Gyeonggi-do
Korea, Republic of	Hallym University Sacred Heart Hospital	Gyeonggi-Do
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Thailand	Division of Nutrition and Biochemical Medicine	Bangkok
Thailand	King Chulalongkorn Memorial Hospital_Bangkok	Bangkok
Thailand	Obstetrics&Gynecology King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Siriraj Hospital_Bangkok_1	Bangkok
Thailand	Siriraj Institute of Clinical Research	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Korea, Republic of,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Percentage	From baseline (week 0) to end of treatment (week 44)
Primary	At least 5% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
Secondary	At least 10% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
Secondary	At least 15% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in waist circumference	cm	From baseline (week 0) to end of treatment (week 44)
Secondary	At least 20% body weight reduction (yes/no)	Count of participant	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in body weight	kg	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in body mass index	kg/m^2	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in systolic blood pressure	mmHg	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in diastolic blood pressure	mmHg	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in total cholesterol	mg/dL	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in total cholesterol	mmol/L	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in high-density lipoprotein (HDL) cholesterol	mg/dL	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in high-density lipoprotein (HDL) cholesterol	mmol/L	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in low-density lipoprotein (LDL) cholesterol	mg/dL	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in low-density lipoprotein (LDL) cholesterol	mmol/L	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in triglycerides	mg/dL	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in triglycerides	mmol/L	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in high-sensitivity c-reactive protein (hsCRP)	mg/L	From baseline (week 0) to end of treatment (week 44)