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

January 12, 2026 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4G2
        • CHU de Quebec-Universite Laval
      • Québec, Canada, G1V 4G5
        • Institut universitaire de cardiologie
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • University of Calgary
      • Calgary, Alberta, Canada, T2H 2G4
        • LMC Clin Res Inc. Calgary
      • Calgary, Alberta, Canada, T2V 4J2
        • C-endo Diab Endo Clin Calgery
      • Edmonton, Alberta, Canada, T6G 2R3
        • Weight Wise Clinic
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Ocean West Research Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • G.A. Research Associates Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Hlth Halifax
    • Ontario
      • Barrie, Ontario, Canada, L4N 7L3
        • LMC Diabetes & Endocrinology (Barrie)
      • Brampton, Ontario, Canada, L6S 0C6
        • LMC ClinRsrh Inc.Brampton
      • Concord, Ontario, Canada, L4K 4M2
        • LMC Clin Res Inc. Thornhill
      • Etobicoke, Ontario, Canada, M9R 4E1
        • LMC Endo Ctr (Etobicoke) Ltd
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Med Clin Trials
      • Hamilton, Ontario, Canada, L8M 1K7
        • Premier Clinical Trial Research Network (PCTRN)
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research
      • Nepean, Ontario, Canada, K2J 0V2
        • LMC Research Inc. Ottawa
      • Oakville, Ontario, Canada, L6M 1M1
        • LMC Clinical Research Inc. Oakville
      • Toronto, Ontario, Canada, M6G 1M2
        • Diabetes Heart Research Centre
      • Toronto, Ontario, Canada, M4G 3E8
        • Centricity Research LMC
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr Anil K Gupta Med Prof Corp
      • Toronto, Ontario, Canada, M4P 1P2
        • Toronto Sleep Institute/MedSleep
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Manna Research Mirabel
      • Montreal, Quebec, Canada, H4N 2W2
        • Centre Medical Acadie
      • Montreal, Quebec, Canada, QC H2L 4E9
        • Clinique Medicine Urbaine du Quartier Latin, Inc.
      • Saint-Laurent, Quebec, Canada, H4T 1Z9
        • LMC Clin Rsrch Inc. (Montreal)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de Recherche du CHUS
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Ctr de méd métab de Lanaudière
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital Diabetes og Hormonsygdomme
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital Endokrinologisk forsknings afsnit 159
  • Finland
      • Helsinki, Finland, 00014
        • Obesity Research Unit
      • Jyväskylä, Finland, 40620
        • StudyCor
  • Spain
      • Madrid, Spain, 28009
        • Hospital Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Seville, Spain, 41010
        • Hospital Infanta Luisa
  • United Kingdom
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • The Health Centre
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry - WISDEM Centre
      • Exmouth, United Kingdom, EX8 2JF
        • Claremont Medical Practice
      • Harrow, United Kingdom, HA2 0RQ
        • GP Direct
      • London, United Kingdom, SE1 9RT
        • Guys Hospital
      • Soham, United Kingdom, CB7 5JD
        • The Staploe Medical Centre
      • Strensall, United Kingdom, YO32 5UA
        • MyHealth - Strensall Health Care Centre
    • South Yorkshire
      • Rotherham, South Yorkshire, United Kingdom, S65 1DA
        • Clifton Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Weight (Percentage [%])
Time Frame: From randomisation (week 0) to end of treatment (week 52)
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
Time Frame: At week 52
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in glycosylated haemoglobin (HbA1c) 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)
Change in Fasting Plasma Glucose (FPG)
Time Frame: 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) 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)
Change in Waist Circumference
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in waist circumference 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)
Change in Systolic Blood Pressure
Time Frame: 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) 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)
Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. 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)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. 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)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. 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)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. 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)
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. 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)
Change in Body Weight (Kilogram [Kg])
Time Frame: From randomisation (week 0) to week 52
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 week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)
Time Frame: At week 52
Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at 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.
At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)
Time Frame: At week 52
Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at 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.
At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)
Time Frame: At week 52
Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at 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.
At week 52
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)
Time Frame: At week 52
Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at 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.
At week 52
Change in Pulse
Time Frame: From randomisation (week 0) to end of treatment (week 52)
Change in pulse 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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