A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight (STEP Young)

• ClinicalTrials.gov Identifier: NCT05726227
• Recruitment Status: Recruiting
• First Posted: February 13, 2023
• Last Update Posted: May 7, 2024
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.

The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: Semaglutide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Long-term Safety and Efficacy of Semaglutide s.c. Once-weekly on Weight Management in Children and Adolescents (Aged 6 to <18 Years) With Obesity or Overweight
• Actual Study Start Date: July 7, 2023
• Estimated Primary Completion Date: November 7, 2025
• Estimated Study Completion Date: January 15, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group Kids; Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.	Drug: Semaglutide; Semaglutide will be administered subcutaneously once weekly.; Drug: Placebo; Placebo will be administered subcutaneously once-weekly.
Experimental: Group Teens; Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.	Drug: Semaglutide; Semaglutide will be administered subcutaneously once weekly.; Drug: Placebo; Placebo will be administered subcutaneously once-weekly.

Outcome Measures

Primary Outcome Measures :

1. Group Kids: Change in body mass index (BMI) [ Time Frame: From baseline (week 0) to week 68 ]
   Measured in percentage (%)

Secondary Outcome Measures :

1. Group Kids: Improvement in weight category [ Time Frame: From baseline (week 0) to week 68 ]
   Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
2. Group Teens: Change in BMI [ Time Frame: From week 0 to week 68 ]
   Measured in %
3. Group Kids and Group Teens: Change in BMI [ Time Frame: From week 0 to week 104 ]
   Measured in %
4. Group Teens: Improvement in weight category [ Time Frame: From week 0 to week 68 ]
   Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
5. Group Kids and Group Teens: Improvement in weight category [ Time Frame: From week 0 to week 104 ]
   Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
6. Group Kids and Group Teens: Change in body weight [ Time Frame: From week 0 to week 68 ]
   Measured in percentage
7. Group Kids and Group Teens: Change in body weight [ Time Frame: From week 0 to week 104 ]
   Measured in percentage
8. Group Kids and Group Teens: Change in body weight [ Time Frame: From week 0 to week 68 ]
   Measured in kilograms (kg)
9. Group Kids and Group Teens: Change in body weight [ Time Frame: From week 0 to week 104 ]
   Measured in kilograms (kg)
10. Group Kids and Group Teens: Change in BMI percentage of the 95th percentile [ Time Frame: From week 0 to week 68 ]
    Measured in percentage points
11. Group Kids and Group Teens: Change in BMI percentage of the 95th percentile [ Time Frame: From week 0 to week 104 ]
    Measured in percentage points
12. Group Kids and Group Teens: Change in BMI Standard deviation score (SDS) [ Time Frame: From week 0 to week 68 ]
    Measured as score on a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
13. Group Kids and Group Teens: Change in BMI SDS [ Time Frame: From week 0 to week 104 ]
    Measured as score in a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
14. Group Kids and Group Teens: Change in waist circumference [ Time Frame: From week 0 to week 68 ]
    Measured in centimeters (cm)
15. Group Kids and Group Teens: Change in waist circumference [ Time Frame: From week 0 to week 104 ]
    Measured in centimeters (cm)
16. Group Kids and Group Teens: Change in systolic blood pressure [ Time Frame: From week 0 to week 68 ]
    Measured in millimeters of mercury (mmHg)
17. Group Kids and Group Teens: Change in systolic blood pressure [ Time Frame: From week 0 to week 104 ]
    Measured in millimeters of mercury (mmHg)
18. Group Kids and Group Teens: Change in diastolic blood pressure [ Time Frame: From week 0 to week 68 ]
    Measured in mmHg
19. Group Kids and Group Teens: Change in diastolic blood pressure [ Time Frame: From week 0 to week 104 ]
    Measured in mmHg
20. Group Kids and Group Teens: Change in total cholesterol [ Time Frame: From week 0 to week 68 ]
    Measured in %
21. Group Kids and Group Teens: Change in total cholesterol [ Time Frame: From week 0 to week 104 ]
    Measured in %
22. Group Kids and Group Teens: Change in high density lipoprotein (HDL) [ Time Frame: From week 0 to week 68 ]
    Measured in %
23. Group Kids and Group Teens: Change in high density lipoprotein (HDL) [ Time Frame: From week 0 to week 104 ]
    Measured in %
24. Group Kids and Group Teens: Change in low density lipoprotein (LDL) [ Time Frame: From week 0 to week 68 ]
    Measured in %
25. Group Kids and Group Teens: Change in low density lipoprotein (LDL) [ Time Frame: From week 0 to week 104 ]
    Measured in %
26. Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) [ Time Frame: From week 0 to week 68 ]
    Measured in %
27. Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) [ Time Frame: From week 0 to week 104 ]
    Measured in %
28. Group Kids and Group Teens: Change in triglycerides [ Time Frame: From week 0 to week 68 ]
    Measured in %
29. Group Kids and Group Teens: Change in triglycerides [ Time Frame: From week 0 to week 104 ]
    Measured in %
30. Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) [ Time Frame: From week 0 to week 68 ]
    Measured in %
31. Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) [ Time Frame: From week 0 to week 104 ]
    Measured in %
32. Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) [ Time Frame: From week 0 to week 68 ]
    Measured in % point
33. Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) [ Time Frame: From week 0 to week 104 ]
    Measured in % point
34. Group Kids and Group Teens: Change in fasting plasma glucose [ Time Frame: From week 0 to week 68 ]
    Measured in millimoles per liter (mmol/L)
35. Group Kids and Group Teens: Change in fasting plasma glucose [ Time Frame: From week 0 to week 104 ]
    Measured in millimoles per liter (mmol/L)
36. Group Kids and Group Teens: Change in fasting plasma glucose [ Time Frame: From week 0 to week 68 ]
    Measured in milligrams per deciliter (mg/dL)
37. Group Kids and Group Teens: Change in fasting plasma glucose [ Time Frame: From week 0 to week 104 ]
    Measured in milligrams per deciliter (mg/dL)
38. Group Kids and Group Teens: Change in fasting insulin [ Time Frame: From week 0 to week 68 ]
    Measured in %
39. Group Kids and Group Teens: Change in fasting insulin [ Time Frame: From week 0 to week 104 ]
    Measured in %
40. Group Kids and Group Teens: Change in alanine transaminase (ALT) [ Time Frame: From week 0 to week 68 ]
    Measured in milliunits per liter (mU/L)
41. Group Kids and Group Teens: Change in alanine transaminase (ALT) [ Time Frame: From week 0 to week 104 ]
    Measured in milliunits per liter (mU/L)
42. Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass [ Time Frame: From week 0 to week 68 ]
    Measured in % points
43. Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass [ Time Frame: From week 0 to week 104 ]
    Measured in % points
44. Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass [ Time Frame: From week 0 to week 68 ]
    Measured in % points
45. Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass [ Time Frame: From week 0 to week 104 ]
    Measured in % points
46. Group Kids and Group Teens: Relative change in visceral fat mass by DXA [ Time Frame: From week 0 to week 68 ]
    Measured in %
47. Group Kids and Group Teens: Relative change in visceral fat mass by DXA [ Time Frame: From week 0 to week 104 ]
    Measured in %
48. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) [ Time Frame: From week 0 to week 68 ]
    Measured in count of participants
49. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) [ Time Frame: From week 0 to week 104 ]
    Measured in count of participants
50. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) [ Time Frame: From week 0 to week 68 ]
    Measured in count of participants
51. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) [ Time Frame: From week 0 to week 104 ]
    Measured in count of participants
52. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) [ Time Frame: From week 0 to week 68 ]
    Measured in count of participants
53. Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) [ Time Frame: From week 0 to week 104 ]
    Measured in count of participants
54. Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) [ Time Frame: From week 0 to week 68 ]
    Measured as count of events
55. Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) [ Time Frame: From week 0 to week 111 ]
    Measured as count of events
56. Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) [ Time Frame: From week 0 to week 68 ]
    Measured as count of events
57. Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) [ Time Frame: From week 0 to week 111 ]
    Measured as count of events
58. Group Kids and Group Teens: Change in pulse [ Time Frame: From week 0 to week 68 ]
    Measured as beats per minute
59. Group Kids and Group Teens: Change in pulse [ Time Frame: From week 0 to week 104 ]
    Measured as beats per minute
60. Group Kids and Group Teens: Change in amylase [ Time Frame: From week 0 to week 68 ]
    Measured as units per liter (U/L)
61. Group Kids and Group Teens: Change in amylase [ Time Frame: From week 0 to week 104 ]
    Measured as units per liter (U/L)
62. Group Kids and Group Teens: Change in lipase [ Time Frame: From week 0 to week 68 ]
    Measured as U/L
63. Group Kids and Group Teens: Change in lipase [ Time Frame: From week 0 to week 104 ]
    Measured as U/L
64. Group Kids and Group Teens: Change in calcitonin [ Time Frame: From week 0 to week 68 ]
    Measured as nanograms per liter (ng/L)
65. Group Kids and Group Teens: Change in calcitonin [ Time Frame: From week 0 to week 104 ]
    Measured as nanograms per liter (ng/L)
66. Group Kids and Group Teens: Change in bone mineral density, by DXA [ Time Frame: From week 0 to week 68 ]
    Measured as grams per square centimeter (g/cm^2)
67. Group Kids and Group Teens: Change in bone mineral density, by DXA [ Time Frame: From week 0 to week 104 ]
    Measured as grams per square centimeter (g/cm^2)
68. Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) [ Time Frame: From week 0 to week 68 ]
    Measured as count of episodes
69. Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) [ Time Frame: From week 0 to week 111 ]
    Measured as count of episodes

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
• Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1
• Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)
• History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months
• Body weight of greater than 45 kilogram (kg) at screening and randomisation
• For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening

Exclusion Criteria:

• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
• Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening
• Type 1 diabetes mellitus or monogenic diabetes
• Participants with endocrine, hypothalamic, or syndromic obesity
• For participants with T2D at screening, the following additional key criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Contacts and Locations

Contacts

Contact: Novo Nordisk; (+1) 866-867-7178; clinicaltrials@novonordisk.com

Locations

United States, California

Neighborhood Healthcare; Active, not recruiting

Escondido, California, United States, 92025

United States, Connecticut

Yale School of Medicine; Active, not recruiting

New Haven, Connecticut, United States, 06519

United States, Georgia

Columbus Research Foundation; Active, not recruiting

Columbus, Georgia, United States, 31904

Eastside Bariatric and Gen Surg; Active, not recruiting

Snellville, Georgia, United States, 30078

United States, Idaho

Solaris Clinical Research; Active, not recruiting

Meridian, Idaho, United States, 83646

United States, Louisiana

Pennington Biom Res Ctr; Active, not recruiting

Baton Rouge, Louisiana, United States, 70808

Pennington Biom Res Ctr; Recruiting

Baton Rouge, Louisiana, United States, 70808

Clinical Trials of America LLC; Active, not recruiting

Monroe, Louisiana, United States, 71201

Clinical Trials of America LLC; Recruiting

Monroe, Louisiana, United States, 71201

United States, Maryland

Barry J. Reiner, MD LLC; Active, not recruiting

Baltimore, Maryland, United States, 21229

United States, Massachusetts

Massachusetts General Hospital_Cary; Withdrawn

Boston, Massachusetts, United States, 02114

United States, Minnesota

University of Minnesota; Active, not recruiting

Minneapolis, Minnesota, United States, 55414

United States, Mississippi

Mississippi Center for Advanced Medicine; Not yet recruiting

Madison, Mississippi, United States, 39110

Mississippi CTR for ADV MED; Withdrawn

Madison, Mississippi, United States, 39110

United States, New York

UBMD Peds-Div of Endo/Diabetes; Active, not recruiting

Buffalo, New York, United States, 14203

United States, North Carolina

WakeMed Childn Endo-Dbt_Raleig; Withdrawn

Raleigh, North Carolina, United States, 27610

United States, North Dakota

Valley Weight Loss Clinic; Active, not recruiting

Fargo, North Dakota, United States, 58104

United States, Ohio

Centricity Research - Ohio; Active, not recruiting

Columbus, Ohio, United States, 43213

United States, Pennsylvania

UPMC Child Hosp-Pittsburgh; Active, not recruiting

Pittsburgh, Pennsylvania, United States, 15224

United States, Tennessee

Vanderbilt University Medical Center; Withdrawn

Nashville, Tennessee, United States, 37212

Tullahoma Pediatrics PLLC; Active, not recruiting

Tullahoma, Tennessee, United States, 37388

United States, Texas

Texas Diabetes & Endocrinology; Active, not recruiting

Austin, Texas, United States, 78731

Univ Of Texas Hlth Science Cntr; Active, not recruiting

San Antonio, Texas, United States, 78207

United States, Virginia

Health Res of Hampton Roads; Active, not recruiting

Newport News, Virginia, United States, 23606

Health Res of Hampton Roads; Recruiting

Newport News, Virginia, United States, 23606

United States, Wisconsin

Marshfield Clinic; Withdrawn

Marshfield, Wisconsin, United States, 54449

Austria

Universitätsklinik Kinder-Jugendheilkunde; Recruiting

Innsbruck, Austria, 6020

Universitätsklinik für Kinder und Jugendheilkunde Haus E; Recruiting

Salzburg, Austria, 5020

Belgium

UZ Brussel; Recruiting

Brussel, Belgium, 1090

UZ Antwerpen - UZA - Kinderziekenhuis; Recruiting

Edegem, Belgium, 2650

UZA - UZ Antwerpen - Kinderziekenhuis; Recruiting

Edegem, Belgium, 2650

UZ Leuven - Kindergeneeskunde; Recruiting

Leuven, Belgium, 3000

Denmark

Aalborg Universitetshospital; Recruiting

Aalborg, Denmark, 9000

Aarhus Universitetshospital, Steno Diabetes Center Aarhus; Recruiting

Aarhus, Denmark, 8200

Holbæk Sygehus; Recruiting

Holbæk, Denmark, 4300

Germany

Universitätsklinikum Halle (Saale); Withdrawn

Halle, Germany, 06120

Kinder- und Jugendkrankenhaus; Recruiting

Hannover, Germany, 30173

Kinder- und Jugendkrankenhaus; Not yet recruiting

Hannover, Germany, 30173

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin; Recruiting

Leipzig, Germany, 04103

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin; Not yet recruiting

Leipzig, Germany, 04103

Universitätsklinikum Ulm für Kinder- und Jugendmedizin; Recruiting

Ulm, Germany, 89075

Universitätsklinikum Ulm für Kinder- und Jugendmedizin; Not yet recruiting

Ulm, Germany, 89075

Israel

Rambam Medical Center Children A Dept.; Recruiting

Haifa, Israel, 31096

Endrocrinology & DM Schneider MC; Recruiting

Petah Tikva, Israel, 49202

Shamir (Assaf Harofe) Medical Center; Recruiting

Zerifin, Israel, 70300

Mexico

Consultorio de Endocrinología y Pediatría; Not yet recruiting

Puebla, Mexico, 72190

Portugal

Hospital da Luz; Recruiting

Lisboa, Portugal, 1500-650

Centro Hospitalar do Porto, E.P.E; Recruiting

Porto, Portugal, 4050-342

CUF-Porto; Recruiting

Porto, Portugal, 4100-180

Sweden

Drottning Silvias barnsjukhus; Withdrawn

Göteborg, Sweden, 41650

Hallands sjukhus Halmstad; Recruiting

Halmstad, Sweden, 30233

Akademiska sjukhuset Uppsala; Recruiting

Uppsala, Sweden, 75185

Akademiska sjukhuset Uppsala; Not yet recruiting

Uppsala, Sweden, 75185

United Kingdom

Birmingham Children's Hospital; Recruiting

Birmingham, United Kingdom, B4 6NH

University Hospitals Bristol & Weston NHS Foundation Trust; Recruiting

Bristol, United Kingdom, BS2 8BJ

Leeds Children's Hospital; Recruiting

Leeds, United Kingdom, LS1 3EX

Alder Hey Children's Hospital; Recruiting

Liverpool, United Kingdom, L12 2AP

Alder Hey Children's Hospital; Not yet recruiting

Liverpool, United Kingdom, L12 2AP

Southampton General Hospital; Withdrawn

Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency dept. 2834; Novo Nordisk A/S

More Information

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05726227
• Other Study ID Numbers: NN9536-4512; U1111-1266-3808 ( Other Identifier: World Health Organization (WHO) ); 2022-502922-41 ( EudraCT Number )
• First Posted: February 13, 2023
• Last Update Posted: May 7, 2024
• Last Verified: May 2024

Individual Participant Data (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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Semaglutide; Glucagon-Like Peptide-1 Receptor Agonists; Hypoglycemic Agents; Physiological Effects of Drugs