A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes (PIONEER TEENS)

Efficacy and Safety of Oral Semaglutide Versus Placebo Both in Combination With Metformin and/or Basal Insulin in Children and Adolescents With Type 2 Diabetes

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Oral semaglutide; Drug: Placebo (semaglutide)

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Children's Hospital- The Clinical Research Centre
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • Women's & Children's Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Children's Hospital
    • Parkville, Victoria, Australia, 3052
      • Murdoch Children's Research Institute
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Perth Children's Hospital
• Austria
  • Salzburg, Austria, 5020
    • Universitätsklinik für Kinder und Jugendheilkunde Haus E
• Belgium
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
  • Namur, Belgium, 5000
    • CHU - UCL Namur - Site Sainte Elisabeth_Namur_1
• Czechia
  • Ostrava-Poruba, Czechia, 708 00
    • Fakultni Nemocnice Ostrava
  • Ústí nad Labem, Czechia, 40011
    • Masarykova nemocnice v Usti nad Labem, o.z. - Detska klinika
• Greece
  • Athens, Greece, GR-11526
    • Henry Dunant Hospital Center,2nd Internal Medicine Clinic
  • Athens, Greece, 15125
    • Iatriko Athinon (Athens Medical Canter)
  • Athens, Greece, 12462
    • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center,2nd Internal Medicine Clinic
  • Athens, Greece, 15125
    • Athens Paediatric Center
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina, Endocrinology
  • Lamia, Greece, GR35100
    • General Hospital of Lamia
  • Lamia, Greece, 35100
    • General Hospital of Lamia
  • Larissa, Greece, GR-41110
    • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
  • Larissa, Greece, 41110
    • Univ Gen Hospital Larisa
  • Penteli, Athens, Greece, 15236
    • Pentelis Children's Hospital - Pediatric Clinic
  • Thessaloniki, Greece, 54636
    • "AHEPA" University General Hospital of Thessaloniki
  • Thessaloniki, Greece, 54645
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
  • Attica
    • Athens, Attica, Greece, 12462
      • University Hospital of Athens ATTIKON
    • Haidari-Athens, Attica, Greece, GR-12462
      • University Hospital of Athens ATTIKON
• India
  • Thriruvananthapuram, India, 695 032
    • Jothydev's Diabetes & Research Center
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Endolife Specialty Hospitals
  • Maharashtra
    • Kolhāpur, Maharashtra, India, 416008
      • Excel Endocrine Centre
    • Mumbai, Maharashtra, India, 400016
      • P D Hinduja National Hospital and Medical Research Centre
  • New Delhi
    • New Dehli, New Delhi, India, 110029
      • All India Institute of Medical Sciences
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Eternal Heart Care Centre
  • Telangana
    • Hyderabad, Telangana, India, 500072
      • Ramdev Rao Hospital
    • Hyderabad, Telangana, India, 50082
      • Dr P V Rao - Diabetes Research Centre
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • SSKM
• Israel
  • Beersheba, Israel, 84101
    • Soroka MC - Pediatric Endocrinology
  • Haifa, Israel, 31096
    • Rambam MC - Department of Pediatrics A
• Lebanon
  • Hazmiyeh, Lebanon, 21211
    • Chronic Care Center
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Putrajaya, Malaysia, 62250
    • Hospital Putrajaya
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
• Mexico
  • Puebla City, Mexico, 72190
    • Consultorio de Endocrinología y Pediatría
• Morocco
  • Rabat, Morocco, 10000
    • Hôpital d'Enfants
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Zkh
  • Almere Stad, Netherlands, 1315 RC
    • De Kinderkliniek
• New Zealand
  • Grafton, New Zealand, 1023
    • Liggins Institute
• North Macedonia
  • Skopje, North Macedonia, 1000
    • PHI University Clinic for Children's Diseases-Skopje
• Portugal
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz Lisboa, S.A.
  • Lisbon, Portugal, 1649-035
    • Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
  • Vila Nova de Gaia, Portugal, 4400-129
    • ULS De Gaia/Espinho_H.Santos Silva_Pediatria
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce Med School Found Inc
• Romania
  • Brasov, Romania, 500260
    • Diabet Center SRL
  • Bucharest, Romania, 041451
    • Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
  • Constanța, Romania, 900591
    • Emergency County Hospital Constanta
  • Dâmbovița County
    • Targoviste, Dâmbovița County, Romania, 130083
      • Spitalul Judetean de Urgenta Targoviste
• Russia
  • Izhevsk, Russia, 426009
    • Republic Children's Hospital of Ministry of Health of Udmurt
  • Moscow, Russia, 125373
    • RMAPE
  • Novosibirsk, Russia, 630048
    • NSMU paediatric clinic
  • Omsk, Russia, 644001
    • GFHI Omsk Region "Regional Children's Clinical Hospital"
  • Saint Petersburg, Russia, 191144
    • SPSBHI City Children out-patient clinic #44
  • Tomsk, Russia, 634050
    • Siberian State Medical University
  • Yekaterinburg, Russia, 620149
    • SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"
• Taiwan
  • Taipei, Taiwan, 104
    • Taipei Mackay Memorial Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
• Ukraine
  • Dnipro, Ukraine, 49023
    • CNPE "City Clinical Hospital #9 Dnipro City Council"
  • Dnipro, Ukraine, 49023
    • City Clinical Hospital #9 (Dnipro) - Endocrinology department
  • Kharkiv, Ukraine, 61093
    • Kharkiv Regional Children's Clinical Hospital - Endocrinological department
  • Kiev, Ukraine, 01021
    • Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology
  • Kyiv, Ukraine, 03039
    • "Verum clinic" LLC
  • Kyiv, Ukraine, 04114
    • Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
  • Vinnytsia, Ukraine, 21010
    • Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Children's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Ped Endo Children's Hosp
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles - Endocrinology
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Chld Clnc Jacksonville
    • Pensacola, Florida, United States, 32514
      • Nemours Children's Health
    • Tampa, Florida, United States, 33612
      • University of South Florida Diabetes Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare Atlanta
    • Columbus, Georgia, United States, 31904
      • Columbus Research Foundation
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Uni School of Med-Ped
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University Of Louisville Research Foundation
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4124
      • Pennington Biomed Res Ctr
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Barry J. Reiner, MD LLC
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • UBMD Peds-Div of Endo/Diabetes
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Child Hosp-Pittsburgh
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Rsrch
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Tech University HSC
    • San Antonio, Texas, United States, 78207
      • Univ Of Texas Hlth Science Cntr
    • San Antonio, Texas, United States, 78233
      • NE Clin Res of San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Pediatric Endo UVHS
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth Univ
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University_Richmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female, aged 10 to below 18 years at the day of randomisation
• HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive)
• Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:
• stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or
• stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or
• stable dose of basal insulin

Exclusion Criteria:

• Diagnosis of type 1 diabetes
• Maturity onset diabetes of the young (MODY)
• Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide - max. tolerated dose; Participants will receive semaglutide tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.	Drug: Oral semaglutide; Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
Placebo Comparator: Placebo (semaglutide); Participants will receive semaglutide placebo tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.	Drug: Placebo (semaglutide); Placebo treatment for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point	This outcome measure reports change from baseline to week 26 in HbA1c measured in terms of percentage point.	Baseline (Week 0), Week 26
Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol)	This outcome measure reports change from baseline to week 26 in HbA1c in terms of mmol/mol.	Baseline (Week 0), Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26	This outcome measure reports change from baseline in FPG to week 26 measured in terms of milligrams per deciliter (mg/dL).	Baseline (Week 0), Week 26
Change From Baseline (Week 0) in Body Mass Index (BMI) Standard Deviation Score (SDS) to Week 26	This outcome measure reports change from baseline to week 26 in BMI measured in terms of the SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method as: Z = ([BMI/M)]^L-1)/ L×S where: L=Skewness (Box-Cox power); M=Median; S= (Coefficient of Variation).	Baseline (Week 0), Week 26
Change From Baseline in HbA1c at Week 52 (Percentage Point)	This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of percentage point.	Baseline (Week 0), Week 52
Change From Baseline in HbA1c at Week 52 (mmol/Mol)	This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of mmol/mol.	Baseline (Week 0), Week 52
Change From Baseline in Fasting Plasma Glucose at Week 52 (mg/dL)	This outcome measure reports change from baseline to week 52 in FPG measured in terms of mg/dL.	Baseline (Week 0), Week 52
Change From Baseline in Body Weight to Week 26 and Week 52 (Kilograms [kg])	This outcome measure reports change from baseline to week 26 and week 52 in body weight measured in terms of kg.	Baseline (Week 0), Week 26, Week 52
Relative Change From Baseline in Body Weight to Week 26 and Week 52	This outcome measure reports relative change from baseline to week 26 and week 52 in body weight measured in terms of percent change.	Baseline (Week 0), Week 26, Week 52
Change From Baseline in Waist Circumference to Week 26 and Week 52	This outcome measure reports change from baseline to week 26 and week 52 in Waist circumference measured in terms of centimeters (cm).	Baseline (Week 0), Week 26, Week 52
Change From Baseline in Body Mass Index Standard Deviation Score at Week 52	This outcome measure reports change from baseline to week 52 in BMI measured in terms of SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method: Z = ([BMI/M)]^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation)	Baseline (Week 0), Week 52
Change From Baseline (Week 0) in BMI Percentile (Age and Gender Adjusted) to Week 26 and Week 52	This outcome measure reports change from baseline (Week 0) in BMI percentile on gender and age-specific growth charts change in terms of percentile of BMI to week 26 and week 52. BMI Percentile was calculated using the CDC 2000 Reference Growth Charts and was derived using the standard LMS method. The CDC reference-specific parameters - L (Lambda), M (Median) and S (Coefficient of Variation) were extracted from the CDC reference tables based on each subject's age (in months) and sex. These parameters were used to compute BMI Z-scores, which were subsequently converted to percentiles using the standard normal distribution function.	Baseline (Week 0), Week 26, Week 52
Change From Baseline in Body Mass Index at Week 26 and Week 52	This outcome measure reports change from baseline to week 52 in BMI measured in terms of Kilograms per meter square (kg/m^2).	Baseline (Week 0), Week 26, Week 52
Percent Change From Baseline in Body Mass Index at Week 26 and Week 52	This outcome measure reports percent change from baseline to week 26 and week 52 in BMI measured in terms of percent change.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Body Mass Index Percentage of the 95th Percentile to Week 26 and to Week 52	This outcome measure reports change from baseline (week 0) in BMI percentage of the 95th percentile in terms of percentage point to week 26 and week 52. BMI Percentage of the 95th Percentile was calculated using the CDC 2000 Reference Growth Charts and was calculated as the ratio of the subject's observed BMI to the CDC age-and-sex-specific 95th percentile BMI reference value, expressed as a percentage.	Baseline (Week 0), Week 26, Week 52
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 26 and Week 52	This outcome measure reports change from baseline in systolic and diastolic blood pressure at week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Percentage of Participants With HbA1c Less Than (<) 7.0% (53 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)	This outcome measure reports percentage of participants with HbA1c <7.0% at week 26 and week 52 in terms of Yes, No, and Missing.	At Week 26 and Week 52
Percentage of Participants With HbA1c Less Than or Equals (≤) 6.5% (48 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)	This outcome measure reports percentage of participants with HbA1c <6.5% (48 mmol/mol) at week 26 and week 52 in terms of Yes, No, and Missing.	At Week 26 and Week 52
Number of Events With Initiation of Additional Anti-diabetic Medication	This outcome measure reports number of events with initiation of additional anti-diabetic medication . Anti-diabetic medication was defined as new anti-diabetic medication and/or intensification of anti-diabetic medication initiated at or after randomization and before (planned) end-of-treatment.	At Week 52
Number of Events With Initiation of Rescue Medication	This outcome measure reports number of events with initiation of rescue medication. Rescue medication is defined as new anti-diabetic medication and/or intensification of antidiabetic medication initiated at or after randomization and before last date on trial product. This is a subset of the additional anti-diabetic medication.	At Week 52
Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product for All Participants	This outcome measure reports number of TEAEs during exposure to trial product for all participants in each arm were assessed up to approximately 57 weeks. Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period.	From Baseline (Week 0) to Week 57
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes From Randomization to Week 26 for All Participants	This outcome measure reports number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes from randomization to week 26. Data reflects the total number of episodes across all participants in each arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the International Society for Paediatric and Adolescent Diabetes (ISPAD) classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?	From Baseline (Week 0) to Week 26
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes, Assessed for 57 Weeks	This outcome measure represented number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product, assessed up to approximately 57 weeks. Data reflects the total number of episodes across all participants in each Arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose).	From Baseline (Week 0) to Week 57
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episode From Randomization to Week 26 (Yes/No)	This outcome measures report number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode from randomization to week 26. AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period.	From Baseline (Week 0) to Week 26
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episode During Exposure to Trial Product, Assessed up to Approximately 57 Weeks (Yes/No)	This outcome measure reports number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product, assessed up to approximately 57 weeks. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?	From Baseline (Week 0) to Week 57
Change From Baseline (Week 0) in Amylase to Week 26 and Week 52	This outcome measure reports change in amylase from baseline (week 0) to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Lipase to Week 26 and Week 52, Ratio to Baseline	This outcome measure reports change in lipase from baseline (week 0) to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Insulin-like Growth Factor 1 (IGF-1) to Week 26 and Week 52	This outcome measure reports change in IGF-1 from baseline (week 0) to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Insulin-Like Growth Factor Binding Protein 3 (IGFBP 3) Serum to Week 26 and Week 52	This outcome measure reports change in IGFBP 3 serum from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Calcitonin to Week 26 and Week 52	This outcome measure reports change in calcitonin from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Estradiol (for Girls) to Week 26 and Week 52	This outcome measure reports change in estradiol from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Testosterone (for Boys) to Week 26 and Week 52	This outcome measure reports change in testosterone (for boys) from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Prolactin to Week 26 and Week 52	This outcome measure reports change in prolactin from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Thyroid Stimulating Hormone (TSH/Thyrotropin) to Week 26 and Week 52	This outcome measure reports change in TSH/thyrotropin from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Follicle Stimulating Hormone (FSH) to Week 26 and Week 52	This outcome measure reports change in FSH from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Luteinizing Hormone (LH) to Week 26 and Week 52	This outcome measure reports change in LH from baseline to week 26 and week 52.	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Dehydroepiandrosterone Sulfate (DHEAS) to Week 26 and Week 52	This outcome measure reports change from baseline to week 26 and week 52 in DHEAS.	Baseline (Week 0), Week 26, Week 52
Anti-semaglutide Antibody Status (Positive/Negative/Missing)	This outcome measure reports anti-semaglutide antibody status as positive, negative, and missing on week 0, week 26, week 52, and week 57.	Week 0, week 26, week 52, and week 57
Anti-semaglutide Antibody Titer	This outcome measure was to report anti-semaglutide antibody titer. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titers at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.	From Week 0 to Week 57
Anti-semaglutide Antibodies With in Vitro Neutralising Effect to Semaglutide	This outcome measure as to report anti-semaglutide antibodies with in vitro neutralising effect to semaglutide from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.	From Week 0 to Week 57
Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Positive/Negative)	This outcome measure reports anti-semaglutide antibodies cross reacting with endogenous GLP-1 status as positive and negative. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.	From Week 0 to Week 57
Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1	This outcome measure reports number of participants with cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study. Hence, anti-semaglutide antibodies assessment could not be performed in this study.	From Week 0 to Week 57
Height Velocity at Week 26 and Week 52	This outcome measure reports height velocity at week 26 and week 52. The height velocity was calculated at week 26 and week 52. Height velocity at week 26 is the difference in height at week 26 and baseline, divided by the actual time elapsed in that period. Height velocity at week 52 is the difference in height at week 26, divided by the actual time elapsed in that period.	At week 26 and week 52
Change From Baseline (Week 0) in Height SDS to Week 26 and Week 52	This outcome measure reports change from baseline in height SDS to week 26 and week 52. Height SDS described individual's height compares to the average height of a reference population of the same age and sex, where a score of 0 represents the population mean, negative values indicate shorter-than-average height, and positive values indicate taller-than-average height. Height SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The Height SDS formula comes from the LMS method: Z = ([Height SDS/M)]^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation).	Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Bone Age Assessment Through X-ray at Week 52	This outcome measure reports change from baseline (week 0) in bone age at week 52 where the assessment was done using X-ray. An X-ray of the left hand and wrist were performed at randomization and at the end of treatment visit for all participants for evaluation of bone age. The X-rays was analyzed by a central reader for determination of bone age.	Baseline (Week 0), Week 52
Change From Baseline (Week 0) in Number of Participants With Pubertal Assessment (Tanner Staging) (Stage 1-5 Where 5 is Full Sexual Maturity) to Week 52	This outcome measure reports change from baseline (week 0) in number of participants with pubertal assessment which was assessed by the Tanner staging in accordance with the stages I-V (stage 1-5 where 5 is full sexual maturity) to week 52. Tanner stage is an overall stage which is the highest stage for girls: Breast development and Pubic hair development; and for boys: genital development and pubic hair development.	Baseline (Week 0), Week 52
Change From Pre-dose to Post-dose (25 and 40 Minutes) in Lactate at Week 12 and Week 26	This outcome measure reports change from pre-dose to post-dose (25 and 40 minutes) in Lactate at week 12 and week 26.	Pre-dose: Baseline (Week 0), Post-dose (25 mins and 40 mins): Week 12 and Week 26
Change From Baseline (Week 0) in Pulse Rate to Week 26 and Week 52	This outcome measure reports change from baseline (week 0) in pulse rate to week 26 and week 52.	Baseline (Week 0), Week 26, and Week 52
Pharmacokinetic (PK): Apparent Clearance (CL/F)	This pharmacokinetic outcome reports CL/F at Week 26: Pre-dose (0 minute before glucose administration) and post dose at 25 and 40 minutes.	Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
PK: Average Concentration (Cavg)	This pharmacokinetic outcome reports Cavg at Week 26.	Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
PK: Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate (SNAC) Plasma Concentrations	This outcome measure reports SNAC plasma concentration at week 12 and week 26.	Week 12 and Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): February 3, 2026

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9924-4437; 2018 (U.S. NIH Grant/Contract); U1111-1218-1527 (Other Identifier: World Health Organization (WHO)); 2018-002952-34 (Registry Identifier: European Medicines Agency (EudraCT))

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: Yes
• Studies a U.S. FDA-regulated device product: No