Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes (STEP 10)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Novo Nordisk Investigational Site
    • Calgary, Alberta, Canada, T2V 4J2
      • Novo Nordisk Investigational Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3Z 2N6
      • Novo Nordisk Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Novo Nordisk Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Novo Nordisk Investigational Site
    • Concord, Ontario, Canada, L4K 4M2
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8L 5G8
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Novo Nordisk Investigational Site
    • London, Ontario, Canada, N5W 6A2
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M4P 1P2
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M6G 1M2
      • Novo Nordisk Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4N 2W2
      • Novo Nordisk Investigational Site
    • Saint-Laurent, Quebec, Canada, H4T 1Z9
      • Novo Nordisk Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Novo Nordisk Investigational Site
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Novo Nordisk Investigational Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Novo Nordisk Investigational Site
  • Hvidovre, Denmark, 2650
    • Novo Nordisk Investigational Site
• Finland
  • Helsinki, Finland, 00014
    • Novo Nordisk Investigational Site
  • Jyväskylä, Finland, 40620
    • Novo Nordisk Investigational Site
• Spain
  • Madrid, Spain, 28009
    • Novo Nordisk Investigational Site
  • Madrid, Spain, 28040
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41010
    • Novo Nordisk Investigational Site
• United Kingdom
  • Bradford-on-Avon, United Kingdom, BA15 1DQ
    • Novo Nordisk Investigational Site
  • Coventry, United Kingdom, CV2 2DX
    • Novo Nordisk Investigational Site
  • Exmouth, United Kingdom, EX8 2JF
    • Novo Nordisk Investigational Site
  • Harrow, United Kingdom, HA2 0RQ
    • Novo Nordisk Investigational Site
  • London, United Kingdom, SE1 9RT
    • Novo Nordisk Investigational Site
  • Soham, United Kingdom, CB7 5JD
    • Novo Nordisk Investigational Site
  • Strensall, United Kingdom, YO32 5UA
    • Novo Nordisk Investigational Site
  • South Yorkshire
    • Rotherham, South Yorkshire, United Kingdom, S65 1DA
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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
Experimental: Semaglutide; Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks	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 Comparator: Placebo (semaglutide); Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks	Drug: Placebo; Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Percentage	From randomisation (week 0) to end of treatment (week 52)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (glycated haemoglobin)	Percentage-points	From randomisation (week 0) to end of treatment (week 52)
Change in FPG (fasting plasma glucose)	measured in mmol/L	From randomisation (week 0) to end of treatment (week 52)
Change in waist circumference	measured in cm	From randomisation (week 0) to end of treatment (week 52)
Change in systolic blood pressure	measured in mmHg	From randomisation (week 0) to end of treatment (week 52)
Change in lipids - Triglycerides	percentage	From randomisation (week 0) to end of treatment (week 52)
Change in lipids - Total cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)
Change in lipids - High density lipoprotein (HDL) cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)
Change in lipids - low density lipoprotein (LDL) cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)
Change in lipids - Very low density lipoprotein (VLDL) cholesterol	percentage	From randomisation (week 0) to end of treatment (week 52)

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): September 6, 2021
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Prediabetic State
• Other Study ID Numbers: NN9536-4734; U1111-1253-1956 (Other Identifier: World Health Organization (WHO)); 2020-002939-29 (EudraCT Number)

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
• product manufactured in and exported from the U.S.: No