Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

NCT05040971 | Completed Phase 3 Results

• 3 other identifiers: NN9536-4734U1111-1253-19562020-002939-29
• Study Type: interventional
• Target: 207
• Locations: 5 countries
• Sites: 43

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight (Percentage [%])

  Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

  From randomisation (week 0) to end of treatment (week 52)

• Participants With Change to Normoglycemia

  Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.

  At week 52

Secondary Outcomes (15)

• Change in Glycosylated Haemoglobin (HbA1c)

  From randomisation (week 0) to end of treatment (week 52)

• Change in Fasting Plasma Glucose (FPG)

  From randomisation (week 0) to end of treatment (week 52)

• Change in Waist Circumference

  From randomisation (week 0) to end of treatment (week 52)

• Change in Systolic Blood Pressure

  From randomisation (week 0) to end of treatment (week 52)

• Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

  From randomisation (week 0) to end of treatment (week 52)

Study Arms (2)

Semaglutide

EXPERIMENTAL

Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks

Drug: Semaglutide 2.4 mg

Placebo (semaglutide)

PLACEBO COMPARATOR

Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks

Drug: Placebo

Interventions

Placebo DRUG

Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week

Placebo (semaglutide)

Semaglutide 2.4 mg DRUG

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

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (43)

LMC Clin Res Inc. Calgary

Calgary, Alberta, T2H 2G4, Canada

Location

University of Calgary

Calgary, Alberta, T2T 5C7, Canada

Location

C-endo Diab Endo Clin Calgery

Calgary, Alberta, T2V 4J2, Canada

Location

Weight Wise Clinic

Edmonton, Alberta, T6G 2R3, Canada

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

LMC Diabetes & Endocrinology (Barrie)

Barrie, Ontario, L4N 7L3, Canada

Location

LMC ClinRsrh Inc.Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

LMC Clin Res Inc. Thornhill

Concord, Ontario, L4K 4M2, Canada

Location

LMC Endo Ctr (Etobicoke) Ltd

Etobicoke, Ontario, M9R 4E1, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8M 1K7, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

LMC Research Inc. Ottawa

Nepean, Ontario, K2J 0V2, Canada

Location

LMC Clinical Research Inc. Oakville

Oakville, Ontario, L6M 1M1, Canada

Location

Centricity Research LMC

Toronto, Ontario, M4G 3E8, Canada

Location

Toronto Sleep Institute/MedSleep

Toronto, Ontario, M4P 1P2, Canada

Location

Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada

Location

Dr Anil K Gupta Med Prof Corp

Toronto, Ontario, M9V 4B4, Canada

Location

Manna Research Mirabel

Mirabel, Quebec, J7J 2K8, Canada

Location

Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada

Location

Clinique Medicine Urbaine du Quartier Latin, Inc.

Montreal, Quebec, QC H2L 4E9, Canada

Location

LMC Clin Rsrch Inc. (Montreal)

Saint-Laurent, Quebec, H4T 1Z9, Canada

Location

Centre de recherché du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, J6X 4P7, Canada

Location

CHU de Quebec-Universite Laval

Québec, G1V 4G2, Canada

Location

Institut universitaire de cardiologie

Québec, G1V 4G5, Canada

Location

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, 8200, Denmark

Location

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, 2650, Denmark

Location

Obesity Research Unit

Helsinki, 00014, Finland

Location

StudyCor

Jyväskylä, 40620, Finland

Location

Hospital Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Infanta Luisa

Seville, 41010, Spain

Location

Clifton Medical Centre

Rotherham, South Yorkshire, S65 1DA, United Kingdom

Location

The Health Centre

Bradford-on-Avon, BA15 1DQ, United Kingdom

Location

University Hospital Coventry - WISDEM Centre

Coventry, CV2 2DX, United Kingdom

Location

Claremont Medical Practice

Exmouth, EX8 2JF, United Kingdom

Location

GP Direct

Harrow, HA2 0RQ, United Kingdom

Location

Guys Hospital

London, SE1 9RT, United Kingdom

Location

The Staploe Medical Centre

Soham, CB7 5JD, United Kingdom

Location

MyHealth - Strensall Health Care Centre

Strensall, YO32 5UA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39089293 RESULT

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: September 6, 2021
• Primary Completion: January 6, 2023
• Study Completion: July 14, 2023
• Last Updated: January 29, 2026
• Results First Posted: October 28, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (28); GB (8); DK (2); ES (3); FI (2)