Research study looking at how well semaglutide works in people living with obesity and prediabetes

Phase 1

• Conditions: Obesity; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-002939-29-ES
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-09
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

- Male or female aged above 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:
a) HbA1c between 6.0 and 6.4 % (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.
b) FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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 % (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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the superiority of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo, both as adjuncts to a reduced-calorie diet and increased physical activity in subjects with obesity and prediabetes, on body weight and reversal to normoglycemia.;Secondary Objective: 1. To compare the efficacy of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo on: <br>•glucose metabolism <br>•cardiovascular risk factors <br>•other factors related to body weight<br>2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo.;Primary end point(s): 1. Change in body weight<br>2. 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);Timepoint(s) of evaluation of this end point: 1.-2. From randomisation (week 0) to end of treatment (week 52)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in HbA1c<br>2. Change in FPG<br>3. Change in waist circumference<br>4. Change in systolic blood pressure<br>5. Change in lipids:<br>a) Triglycerides<br>b)Total cholesterol<br>c) High density lipoprotein (HDL) cholesterol<br>d) Low density lipoprotein (LDL) cholesterol<br>e) Very low density lipoprotein (VLDL) cholesterol;Timepoint(s) of evaluation of this end point: 1.-5. From randomisation (week 0) to end of treatment (week 52)