STEP TEENS Weight Maintenance: A research study on how well semaglutide helps teenagers with excess body weight to lose weight and maintain weight loss

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

18 Feb 2025 → ongoing

Decision date (initial)

2025-02-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2023-508055-40-00

WHO UTN

U1111-1295-4799

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To investigate BMI maintenance with semaglutide administered according to a dose-tapering algorithm in adolescents who have achieved BMI below obesity threshold and are still on-treatment after 1.5 years of initial treatment

Secondary objectives 7

1. To investigate the maintenance of improved BMI category with semaglutide in adolescents who have achieved a reduction in obesity class but still have a BMI above obesity threshold after 1.5 years of initial treatment
2. To investigate the doses of semaglutide given according to a dose-tapering algorithm in adolescents who have achieved BMI below obesity threshold and are still on-treatment after 1.5 years of initial treatment
3. To describe outcomes with semaglutide administered according to a response-dependent strategy in adolescents with obesity with respect to weight-related parameters
4. To describe outcomes with semaglutide administered according to a response-dependent strategy in adolescents with obesity with respect to glucose metabolism
5. To describe outcomes with semaglutide administered according to a response-dependent strategy in adolescents with obesity with respect to cardiometabolic risk factors
6. To describe outcomes with semaglutide administered according to a response-dependent strategy in adolescents with obesity with respect to body composition
7. To investigate the long-term safety of semaglutide administered according to a response-dependent strategy in adolescents with obesity

Conditions and MedDRA coding

Obesity

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001441-PIP03-17

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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
2. Age 12 to <15 years at the time of signing the informed consent
3. BMI ≥95th percentile at screening (on sex- and age-specific BMI growth charts (CDC.gov))
4. Body weight >60 kg at screening

Exclusion criteria 5

1. Prepubertal status (Tanner stage 1)
2. Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
3. 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
4. Endocrine, hypothalamic, or syndromic obesity
5. 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant.

Secondary endpoints 20

1. 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.
2. Tapering to zero dose. From 1.5 years to 3 years. Count of participant.
3. Time/dose steps before ending dose tapering. From 1.5 years to 3 years. Weeks, count of dose steps.
4. 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.
5. 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.
6. Change in BMI. From baseline (day 0) to 1.5 and 3 years. Percent.
7. BMI percentage of the 95th percentile. From baseline (day 0) to 1.5 and 3 years. Percent.
8. Change in BMI SDS. From baseline (day 0) to 1.5 and 3 years. Unitless.
9. Change in waist-to-height ratio (waist [cm]/ height [cm]). From baseline (day 0) to 1.5 and 3 years. Unitless.
10. Change in waist circumference. From baseline (day 0) to 1.5 and 3 years. Cm.
11. Change in HbA1c. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Percentage points.
12. 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.
13. 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.
14. Change in hsCRP. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent.
15. 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.
16. 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.
17. Change in fat mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points.
18. Change in lean body mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points.
19. Relative change in visceral fat mass by DXA. From baseline (day 0) to 1.5 and 3 years. Percent.
20. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 7

Locations

8 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 157 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications