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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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