Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes
NCT ID: NCT05040971
Last Updated: 2026-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2021-09-06
2023-07-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Semaglutide
Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks
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 (semaglutide)
Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks
Placebo
Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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LMC Clin Res Inc. Calgary
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
C-endo Diab Endo Clin Calgery
Calgary, Alberta, Canada
Weight Wise Clinic
Edmonton, Alberta, Canada
Ocean West Research Clinic
Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, Canada
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, Canada
LMC Clin Res Inc. Thornhill
Concord, Ontario, Canada
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, Canada
LMC Clinical Research Inc. Oakville
Oakville, Ontario, Canada
Centricity Research LMC
Toronto, Ontario, Canada
Toronto Sleep Institute/MedSleep
Toronto, Ontario, Canada
Diabetes Heart Research Centre
Toronto, Ontario, Canada
Dr Anil K Gupta Med Prof Corp
Toronto, Ontario, Canada
Manna Research Mirabel
Mirabel, Quebec, Canada
Centre Medical Acadie
Montreal, Quebec, Canada
Clinique Medicine Urbaine du Quartier Latin, Inc.
Montreal, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, Canada
Centre de recherché du CHUS
Sherbrooke, Quebec, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, , Canada
Institut universitaire de cardiologie
Québec, , Canada
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N, , Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, , Denmark
Obesity Research Unit
Helsinki, , Finland
StudyCor
Jyväskylä, , Finland
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Infanta Luisa
Seville, , Spain
Clifton Medical Centre
Rotherham, South Yorkshire, United Kingdom
The Health Centre
Bradford-on-Avon, , United Kingdom
University Hospital Coventry - WISDEM Centre
Coventry, , United Kingdom
Claremont Medical Practice
Exmouth, , United Kingdom
GP Direct
Harrow, , United Kingdom
Guys Hospital
London, , United Kingdom
The Staploe Medical Centre
Soham, , United Kingdom
MyHealth - Strensall Health Care Centre
Strensall, , United Kingdom
Countries
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References
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McGowan BM, Bruun JM, Capehorn M, Pedersen SD, Pietilainen KH, Muniraju HAK, Quiroga M, Varbo A, Lau DCW; STEP 10 Study Group. Efficacy and safety of once-weekly semaglutide 2.4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial. Lancet Diabetes Endocrinol. 2024 Sep;12(9):631-642. doi: 10.1016/S2213-8587(24)00182-7. Epub 2024 Jul 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1253-1956
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002939-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN9536-4734
Identifier Type: -
Identifier Source: org_study_id
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