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

• 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: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: October 1, 2018
• First Posted Date: October 3, 2018
• Results First Submitted Date: February 2, 2022
• Results First Posted Date: March 23, 2022
• Last Update Posted Date: July 6, 2023
• Actual Study Start Date: October 5, 2018
• Actual Primary Completion Date: January 29, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Overweight
• Obesity

Intervention

• 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

• 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 *

• Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
• Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18.
• Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2019): 304
• Original Estimated Enrollment (submitted: October 1, 2018): 88
• Actual Study Completion Date: March 23, 2021
• Actual Primary Completion Date: January 29, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Hungary, Italy, Spain, United States

Administrative Information

• NCT Number: NCT03693430
• Other Study ID Numbers: 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

• 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: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: July 2023