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A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate 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, ages 12 to below 18 years at the time of signing informed consent
BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes
History of at least one self-reported unsuccessful dietary effort to lose weight

For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:

- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening

Exclusion Criteria:

Prepubertal subjects (Tanner stage 1)
History of type 1 diabetes
A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)
For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm Description

2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly

Placebo injected s.c. once weekly .

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI) (Percentage [%])

Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Secondary Outcome Measures

Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)

Percentage of participants who achieved >= 5% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 5% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 5% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Change in Body Weight (Kilograms [kg])

Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Body Weight (%)

Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)

Percentage of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 10% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)

Percentage of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 15% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)

Percentage of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 20% weight reduction, whereas 'No' infers the percentage of participants who did not achieve >= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])

Change from baseline in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) at week 68 is presented. CDC gender and age-specific growth charts: normal (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% of the 95th percentile - <140% of the 95th percentile) and obesity class III (BMI >=140% of the 95th percentile). Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Percentage of Participants Achieving Improvement in Weight Category (Yes/no)

Percentage of participants who achieved improvement in weight category from baseline (week 0) to week 68 is presented. Improvement in weight category was defined as being in a lower weight category at week 68 compared to baseline according to CDC gender and age-specific growth charts: normal (BMI <85th percentile), overweight (BMI >=85th - <95th percentile), obesity class I (BMI >=95th - <120% of the 95th percentile), obesity class II (BMI >=120% of the 95th percentile - <140% of the 95th percentile) and obesity class III (BMI >=140% of the 95th percentile). In the reported data, 'Yes' infers the percentage of participants who have achieved improvement in weight category, whereas 'No' infers the percentage of participants who did not achieve improvement in weight category. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

Change in BMI (Standard Deviation Score [SDS])

Change in BMI SDS from baseline to week 68 is presented. The SDS scores are also called as z-scores. 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 standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (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. Possible values range from -3 to +3, a negative score being beneficial. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in BMI (Kilograms Per Meter Square [kg/m^2])

Change in BMI (kg/m^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Waist Circumference

Change in waist circumference (centimeters [cm]) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)

Percentage of participants who achieved >= 5% reduction of BMI from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved >= 5% BMI reduction, whereas 'No' infers the percentage of participants who did not achieve >= 5% BMI reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.

Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Glycated Haemoglobin (HbA1c) (%)

Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in HbA1c (Millimoles Per Mole [mmol/Mol])

Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])

Change in fasting plasma glucose (mmol/L) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])

Change in fasting plasma glucose (mg/dL) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline

Change in fasting insulin (pmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline

Change in fasting insulin (mIU/mL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Total Cholesterol (mmol/L): Ratio to Baseline

Change in total cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Total Cholesterol (mg/dL): Ratio to Baseline

Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline

Change in HDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline

Change in HDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline

Change in LDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in LDL Cholesterol (mg/dL): Ratio to Baseline

Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline

Change in VLDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in VLDL Cholesterol (mg/dL): Ratio to Baseline

Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Triglycerides (mmol/L): Ratio to Baseline

Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Triglycerides (mg/dL): Ratio to Baseline

Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Change in Alanine Aminotransferase (ALT): Ratio to Baseline

Change in ALT (units per liter [U/L]) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Number of Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period 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 greater than (>) 7 consecutive missed doses (corresponding to >7 weeks off-treatment).

Number of Treatment-emergent Serious Adverse Events (SAEs)

An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period 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 in Pulse

Change in pulse from baseline to week 68 is presented. Data is reported for on-treatment period: the on-treatment period 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 in Amylase: Ratio to Baseline

Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period 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 in Lipase: Ratio to Baseline

Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period 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 in Calcitonin: Ratio to Baseline

Change in calcitonin (nanograms per liter [ng/L]) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period 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).

Full Information

NCT ID

NCT04102189

First Posted

September 23, 2019

Last Updated

March 24, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04102189

Brief Title

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Official Title

Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 7, 2019 (Actual)

Primary Completion Date

March 25, 2022 (Actual)

Study Completion Date

March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo injected s.c. once weekly .

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks

Primary Outcome Measure Information:

Title

Change in Body Mass Index (BMI) (Percentage [%])

Description

Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)

Description

Time Frame

At week 68

Title

Change in Body Weight (Kilograms [kg])

Description

Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Change in Body Weight (%)

Description

Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)

Description

Time Frame

At week 68

Title

Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)

Description

Time Frame

At week 68

Title

Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)

Description

Time Frame

At week 68

Title

Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])

Description

Time Frame

Baseline (week 0), week 68

Title

Percentage of Participants Achieving Improvement in Weight Category (Yes/no)

Description

Time Frame

At week 68

Title

Change in BMI (Standard Deviation Score [SDS])

Description

Time Frame

Baseline (week 0), week 68

Title

Change in BMI (Kilograms Per Meter Square [kg/m^2])

Description

Change in BMI (kg/m^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Change in Waist Circumference

Description

Time Frame

Baseline (week 0), week 68

Title

Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)

Description

Time Frame

At week 68

Title

Change in Systolic Blood Pressure

Description

Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Change in Diastolic Blood Pressure

Description

Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Change in Glycated Haemoglobin (HbA1c) (%)

Description

Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Change in HbA1c (Millimoles Per Mole [mmol/Mol])

Description

Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

Time Frame

Baseline (week 0), week 68

Title

Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Total Cholesterol (mmol/L): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Total Cholesterol (mg/dL): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68:

Title

Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in LDL Cholesterol (mg/dL): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68:

Title

Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in VLDL Cholesterol (mg/dL): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Triglycerides (mmol/L): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Triglycerides (mg/dL): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Alanine Aminotransferase (ALT): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Number of Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From baseline (week 0) to week 75

Title

Number of Treatment-emergent Serious Adverse Events (SAEs)

Description

Time Frame

From baseline (week 0) to week 75

Title

Change in Pulse

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Amylase: Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Lipase: Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

Title

Change in Calcitonin: Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 68

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate 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, ages 12 to below 18 years at the time of signing informed consent BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes History of at least one self-reported unsuccessful dietary effort to lose weight For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition: - HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening Exclusion Criteria: Prepubertal subjects (Tanner stage 1) History of type 1 diabetes A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes) For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114-2621

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27610

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45419

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Stefan

ZIP/Postal Code

8511

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1060

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Dublin

State/Province

Leinster

ZIP/Postal Code

DUBLIN 4

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Puebla

ZIP/Postal Code

72190

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Izhevsk

ZIP/Postal Code

426009

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125373

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630048

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Rostov-on-Don

ZIP/Postal Code

344013

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191144

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Rotherham

State/Province

South Yorkshire

ZIP/Postal Code

S65 1DA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B4 6NH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8AE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

WC1E 6DB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Sheffield

ZIP/Postal Code

S35 9XQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Citations:

PubMed Identifier

36322838

Citation

Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.

Results Reference

result

PubMed Identifier

35797460

Citation

Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.

Results Reference

derived

Learn more about this trial

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

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A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Overweight, Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial