SEMAGLUTIDE for Obesity

Inclusion criteria

• {"criterion_text":"- Informed consent 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: - The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements - The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements\n- Age 12 to <15 years at the time of signing the informed consent\n- BMI ≥95th percentile at screening (on sex- and age-specific BMI growth charts (CDC.gov))\n- Body weight >60 kg at screening"}

Exclusion criteria

• {"criterion_text":"- Prepubertal status (Tanner stage 1)\n- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening\n- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: - Liposuction and/or abdominoplasty, if performed >1 year prior to screening - Adjustable gastric banding, if the band has been removed >1 year prior to screening - Intragastric balloon, if the balloon has been removed >1 year prior to screening - Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year prior to screening\n- Endocrine, hypothalamic, or syndromic obesity\n- History of type 1 or type 2 diabetes mellitus (as declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)."}

Primary endpoints

• {"endpoint_text":"- Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant.","definition_or_measurement_approach":"Count of participants who maintain BMI below the obesity threshold measured between 1.5 and 3 years (maintenance of BMI below obesity threshold)."}

Secondary endpoints

• {"endpoint_text":"- Maintenance of improved BMI category. From 1.5 years to 3 years and end of continued treatment phase (up to 6 years). Count of participant.","definition_or_measurement_approach":"Count of participants maintaining improved BMI category assessed at 1.5 years, 3 years and end of continued treatment phase (up to 6 years)."}
• {"endpoint_text":"- Tapering to zero dose. From 1.5 years to 3 years. Count of participant.","definition_or_measurement_approach":"Count of participants tapered to zero dose between 1.5 and 3 years."}
• {"endpoint_text":"- Time/dose steps before ending dose tapering. From 1.5 years to 3 years. Weeks, count of dose steps.","definition_or_measurement_approach":"Number of weeks and count of dose steps before completion of dose tapering between 1.5 and 3 years."}
• {"endpoint_text":"- Achieving BMI below obesity threshold. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Count of participant.","definition_or_measurement_approach":"Count of participants achieving BMI below obesity threshold at specified timepoints (baseline to 1.5, 3 years and up to 6 years)."}
• {"endpoint_text":"- Achieving any improvement in BMI category. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Count of participant.","definition_or_measurement_approach":"Count of participants achieving any improvement in BMI category at specified timepoints."}
• {"endpoint_text":"- Change in BMI. From baseline (day 0) to 1.5 and 3 years. Percent.","definition_or_measurement_approach":"Percent change in BMI from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- BMI percentage of the 95th percentile. From baseline (day 0) to 1.5 and 3 years. Percent.","definition_or_measurement_approach":"BMI expressed as percentage of the 95th percentile from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- Change in BMI SDS. From baseline (day 0) to 1.5 and 3 years. Unitless.","definition_or_measurement_approach":"Change in BMI standard deviation score (SDS) from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- Change in waist-to-height ratio (waist [cm]/ height [cm]). From baseline (day 0) to 1.5 and 3 years. Unitless.","definition_or_measurement_approach":"Change in waist-to-height ratio from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- Change in waist circumference. From baseline (day 0) to 1.5 and 3 years. Cm.","definition_or_measurement_approach":"Change in waist circumference (cm) from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- Change in HbA1c. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Percentage points.","definition_or_measurement_approach":"Change in HbA1c (percentage points) from baseline to specified timepoints."}
• {"endpoint_text":"- Change in fasting plasma glucose. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). mmol/L, mg/dL.","definition_or_measurement_approach":"Change in fasting plasma glucose (mmol/L and mg/dL) from baseline to specified timepoints."}
• {"endpoint_text":"- Change in fasting insulin and HOMA-IR. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.","definition_or_measurement_approach":"Change in fasting insulin and HOMA-IR (percent) from baseline to specified timepoints."}
• {"endpoint_text":"- Change in hsCRP. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.","definition_or_measurement_approach":"Change in high-sensitivity CRP (percent) from baseline to specified timepoints."}
• {"endpoint_text":"- Change in ALT, total cholesterol, HDL, LDL, VLDL and triglycerides. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.","definition_or_measurement_approach":"Percent change in ALT and lipid parameters from baseline to specified timepoints."}
• {"endpoint_text":"- Change in systolic and diastolic blood pressure. From baseline (day 0) to 1.5 and 3 years and end of continued treatment phase (up to 6 years). mmHg.","definition_or_measurement_approach":"Change in systolic and diastolic blood pressure (mmHg) from baseline to specified timepoints."}
• {"endpoint_text":"- Change in fat mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points.","definition_or_measurement_approach":"Change in fat mass (DXA) relative to total body mass from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- Change in lean body mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points.","definition_or_measurement_approach":"Change in lean body mass (DXA) relative to total body mass from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- Relative change in visceral fat mass by DXA. From baseline (day 0) to 1.5 and 3 years. Percent.","definition_or_measurement_approach":"Relative percent change in visceral fat mass (DXA) from baseline to 1.5 and 3 years."}
• {"endpoint_text":"- SAEs. From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years). Count.","definition_or_measurement_approach":"Count of serious adverse events reported during specified study intervals."}

Italy

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

12-08-2025

Processing Time Days

294

Number Of Sites

5

Number Of Participants

40

Belgium

Earliest CTIS Part Ii Submission Date

31-01-2025

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

465

Number Of Sites

4

Number Of Participants

40

Denmark

Earliest CTIS Part Ii Submission Date

24-01-2025

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

440

Number Of Sites

3

Number Of Participants

20

France

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

506

Number Of Sites

5

Number Of Participants

45

Germany

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

469

Number Of Sites

4

Number Of Participants

30

Greece

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

534

Number Of Sites

5

Number Of Participants

45

Sweden

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

455

Number Of Sites

4

Number Of Participants

34

Poland

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

455

Number Of Sites

7

Number Of Participants

55

Primary sponsor

Full Name

Novo Nordisk A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

Icon (Lr) Limited

Responsibilities

Central Laboratory

Name

4G Clinical B.V.

Responsibilities

RTSM supplier and RTSM help desk

Name

IQVIA Limited

Responsibilities

In-trial interview

Name

Perceptive Informatics Inc.

Responsibilities

Imaging supplier

Name

Clario Medical Imaging Inc.

Responsibilities

eCOA supplier

Name

Eresearchtechnology Inc.

Responsibilities

eCOA supplier

Name

Oracle America Inc.

Responsibilities

CRF supplier:

Third parties

• {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Central Laboratory","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF supplier:","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging supplier","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"eCOA supplier","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier and RTSM help desk","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA supplier","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"In-trial interview","organisation_type":"Pharmaceutical company"}