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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05040971
Recruitment Status : Completed
First Posted : September 10, 2021
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Semaglutide 2.4 mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
Actual Study Start Date : September 6, 2021
Actual Primary Completion Date : January 6, 2023
Actual Study Completion Date : July 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
Drug Information available for: Semaglutide

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in body weight [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    Percentage

  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) [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    Count of subjects


Secondary Outcome Measures :
  1. Change in HbA1c (glycated haemoglobin) [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    Percentage-points

  2. Change in FPG (fasting plasma glucose) [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    measured in mmol/L

  3. Change in waist circumference [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    measured in cm

  4. Change in systolic blood pressure [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    measured in mmHg

  5. Change in lipids - Triglycerides [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    percentage

  6. Change in lipids - Total cholesterol [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    percentage

  7. Change in lipids - High density lipoprotein (HDL) cholesterol [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    percentage

  8. Change in lipids - low density lipoprotein (LDL) cholesterol [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    percentage

  9. Change in lipids - Very low density lipoprotein (VLDL) cholesterol [ Time Frame: From randomisation (week 0) to end of treatment (week 52) ]
    percentage


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05040971


Locations
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Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T2T 5C7
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T2V 4J2
Canada, British Columbia
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3Z 2N6
Canada, New Brunswick
Novo Nordisk Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Ontario
Novo Nordisk Investigational Site
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
Canada, Quebec
Novo Nordisk Investigational Site
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
Denmark
Novo Nordisk Investigational Site
Aarhus N, Denmark, 8200
Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00014
Novo Nordisk Investigational Site
Jyväskylä, Finland, 40620
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28009
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
United Kingdom
Novo Nordisk Investigational Site
Rotherham, South Yorkshire, United Kingdom, S65 1DA
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05040971    
Other Study ID Numbers: NN9536-4734
U1111-1253-1956 ( Other Identifier: World Health Organization (WHO) )
2020-002939-29 ( EudraCT Number )
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Prediabetic State
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs