Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Obesity Clinical Trial

— STEP 10  

Official title:

Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040971
• Other study ID #: NN9536-4734
• Secondary ID: U1111-1253-19562
• Status: Completed
• Phase: Phase 3
• Start date: September 6, 2021
• Est. completion date: July 14, 2023

Study information

• Verified date: November 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. 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. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 14, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged greater than or equal to 18 years at the time of signing informed consent.
• BMI greater than or equal to 30.0 kg/m^2
• Prediabetes defined as at least one of the following:
• HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.
• FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

• History of type 1 or type 2 diabetes.
• Treatment with glucose-lowering agent(s) within 90 days before screening.
• HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.
• FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening. A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
• Treatment with any medication for the indication of obesity within the past 90 days before screening.

Related Conditions & MeSH terms

• Obesity
• Prediabetic State

Intervention

Drug:
• Semaglutide 2.4 mg
Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg
• Placebo
Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Brampton	Ontario
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Concord	Ontario
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	London	Ontario
Canada	Novo Nordisk Investigational Site	Moncton	New Brunswick
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
Canada	Novo Nordisk Investigational Site	Saint-Laurent	Quebec
Canada	Novo Nordisk Investigational Site	Sherbrooke	Quebec
Canada	Novo Nordisk Investigational Site	Surrey	British Columbia
Canada	Novo Nordisk Investigational Site	Terrebonne	Quebec
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Denmark	Novo Nordisk Investigational Site	Aarhus N
Denmark	Novo Nordisk Investigational Site	Hvidovre
Finland	Novo Nordisk Investigational Site	Helsinki
Finland	Novo Nordisk Investigational Site	Jyväskylä
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Sevilla
United Kingdom	Novo Nordisk Investigational Site	Bradford-on-Avon
United Kingdom	Novo Nordisk Investigational Site	Coventry
United Kingdom	Novo Nordisk Investigational Site	Exmouth
United Kingdom	Novo Nordisk Investigational Site	Harrow
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Rotherham	South Yorkshire
United Kingdom	Novo Nordisk Investigational Site	Soham
United Kingdom	Novo Nordisk Investigational Site	Strensall

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  Denmark,  Finland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Percentage	From randomisation (week 0) to end of treatment (week 52)
Primary	Change to normoglycemia (Normoglycemia is defined as having both HbA1c below 6.0% (below 42 mmol/mol) and FPG below 5.5 mmol/L (below 99 mg/dL)	Count of subjects	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in HbA1c (glycated haemoglobin)	Percentage-points	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in FPG (fasting plasma glucose)	measured in mmol/L	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in waist circumference	measured in cm	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in systolic blood pressure	measured in mmHg	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in lipids - Triglycerides	percentage	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in lipids - Total cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in lipids - High density lipoprotein (HDL) cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in lipids - low density lipoprotein (LDL) cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)
Secondary	Change in lipids - Very low density lipoprotein (VLDL) cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)