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Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 5)

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: NCT03693430
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : March 23, 2022
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 3, 2018
Results First Submitted Date  ICMJE February 2, 2022
Results First Posted Date  ICMJE March 23, 2022
Last Update Posted Date July 6, 2023
Actual Study Start Date  ICMJE October 5, 2018
Actual Primary Completion Date January 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2022)
  • Percentage Change From Baseline (Week 0) to Week 104 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
  • Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: At Week 104 ]
    Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Change in body weight [ Time Frame: Week 0, week 104 ]
    Measured in %
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 5% [ Time Frame: Week 0, week 104 ]
    Number of subjects
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2022)
  • Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: At Week 104 ]
    Number of participants who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: At Week 104 ]
    Number of participants who achieved >=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: At Week 104 ]
    Number of participants who achieved >=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in Waist Circumference [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in Body Weight (kg) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Total Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Free Fatty Acids-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Triglycerides-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Glycated Haemoglobin (HbA1c) (Percent [%]) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
  • Percentage Change From Baseline (Week 0) to Week 52 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Percentage change in body weight from baseline (week 0) to week 52 is presented.
  • Change From Baseline (Week 0) to Week 52 in Body Weight (kg) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in body weight from baseline (week 0) to week 52 in kg is presented.
  • Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in BMI from baseline (week 0) to week 52 is presented.
  • Change From Baseline (Week 0) to Week 52 in Waist Circumference [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in waist circumference from baseline (week 0) to week 52 is presented.
  • Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss.
  • Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss.
  • Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss.
  • Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss.
  • Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 111 ]
    An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
  • Number of Serious Adverse Events (SAEs) [ Time Frame: From Baseline (Week 0) to Week 111 ]
    A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
  • Change From Baseline (Week 0) to Week 104 in Pulse [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
  • Change From Baseline (Week 0) to Week 104 in Amylase [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
  • Change From Baseline (Week 0) to Week 104 in Lipase [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
  • Change From Baseline (Week 0) to Week 104 in Calcitonin [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 10% [ Time Frame: Week 0, week 104 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 15% [ Time Frame: Week 0, week 104 ]
    Number of subjects
  • Change in waist circumference [ Time Frame: Week 0, week 104 ]
    Measured in cm
  • Change in systolic blood pressure [ Time Frame: Week 0, week 104 ]
    Measured in mmHg
  • Change in body weight [ Time Frame: Week 0, week 104 ]
    Measured in kg
  • Change in body mass index (BMI) [ Time Frame: Week 0, week 104 ]
    Measured in kg/m^2
  • Change in hemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 104 ]
    Measured in %
  • Change in HbA1c [ Time Frame: Week 0, week 104 ]
    Measured in mmol/mol
  • Change in fasting plasma glucose [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in fasting serum insulin [ Time Frame: Week 0, week 104 ]
    Measured in micro IU/mL
  • Change in diastolic blood pressure [ Time Frame: Week 0, week 104 ]
    Measured in mmHg
  • Change in total cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in very low density lipoprotein (VLDL) cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in free fatty acids [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in triglycerides [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in high sensitivity C-Reactive Protein [ Time Frame: Week 0, week 104 ]
    Measured in mg/L
  • Change in body weight [ Time Frame: Week 0, week 52 ]
    Measured in %
  • Change in body weight [ Time Frame: Week 0, week 52 ]
    Measured in kg
  • Change in BMI [ Time Frame: Week 0, week 52 ]
    Measured in kg/m^2
  • Change in waist circumference [ Time Frame: Week 0, week 52 ]
    Measured in cm
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 5% [ Time Frame: Week 0, week 52 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 10% [ Time Frame: Week 0, week 52 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 15% [ Time Frame: Week 0, week 52 ]
    Number of subjects
  • Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Week 0, week 111 ]
    Number of events
  • Number of serious adverse events (SAEs) [ Time Frame: Week 0, week 111 ]
    Number of events
  • Change in pulse [ Time Frame: Week 0, week 104 ]
    Measured in beats per minute
  • Change in amylase [ Time Frame: Week 0, week 104 ]
    Measured in U/L
  • Change in lipase [ Time Frame: Week 0, week 104 ]
    Measured in U/L
  • Change in calcitonin [ Time Frame: Week 0, week 104 ]
    Measured in ng/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Official Title  ICMJE Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Brief Summary This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. 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 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Drug: Semaglutide
    Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
  • Drug: Placebo (Semaglutide)
    S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
Study Arms  ICMJE
  • Experimental: Semaglutide
    Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo
    Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
    Intervention: Drug: Placebo (Semaglutide)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
304
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
88
Actual Study Completion Date  ICMJE March 23, 2021
Actual Primary Completion Date January 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age more than or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria:

  • HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Hungary,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03693430
Other Study ID Numbers  ICMJE NN9536-4378
2017-003726-32 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1202-1740 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP