DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06571383

Active not recruitingPhase 4

STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

Weight Maintenance in Adolescents With Obesity; Long-Term Treatment With Semaglutide s.c.2.4 mg Once-weekly

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

93

Recruiting sites

—

Enrollment

500

estimated

Study population

Obesity / overweight

Key I/E criterion

•Age 12-15

Primary endpoint

•Maintenance of Body Mass Index (BMI) below obesity threshold

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06571383
Org study IDNN9536-7752
Secondary ID2023-508055-40European Medical Agency (EMA)
Secondary IDU1111-1295-4799World Health Organisation (WHO)

Timeline

Milestones

Study first posted2024-08-26actual
Study start2024-09-17actual
Last update posted2026-06-02actual
Primary completion2028-11-15estimated
Study completion2031-11-15estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age15 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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:

1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements

2. The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements

•Age 12 to less than 15 years at the time of signing the informed consent
•BMI greater than or equal to 95th percentile at screening
•Body weight greater than 60 kg at screening

Exclusion criteria

•Prepubertal status (Tanner stage 1)
•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:

1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening

2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening

3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening

4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening

•Endocrine, hypothalamic, or syndromic obesity
•History of type 1 or type 2 diabetes mellitus

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
12
Glycemic / diabetes
3
Cardiometabolic biomarkers
3
Safety / tolerability / PK
2
Other (unclassified)
1

Weight & body composition

12 endpoints
Primary/protocol endpoint

Maintenance of Body Mass Index (BMI) below obesity threshold

Time frame:From 1.5 years to 3 years

threshold achievement, improvement

Secondary/protocol endpoint

Maintenance of improved Body Mass Index (BMI) category

Time frame:From 1.5 years to 3 years and end of continued treatment phase (up to 6 years)

event count, improvement

Secondary/protocol endpoint

Achieving Body Mass Index (BMI) below obesity threshold

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

threshold achievement, improvement

Secondary/protocol endpoint

Achieving any improvement in Body Mass Index (BMI) category

Time frame:From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years)

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:From baseline (day 0) to 1.5 and 3 years

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Body Mass Index (BMI) percentage of the 95th percentile

Time frame:From baseline (day 0) to 1.5 and 3 years

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index Standard Deviation Score (BMI SDS)

Time frame:From baseline (day 0) to 1.5 and 3 years

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-height ratio (waist [cm]/ height [cm])

Time frame:From baseline (day 0) to 1.5 and 3 years

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (day 0) to 1.5 and 3 years

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass

Time frame:From baseline (day 0) to 1.5 and 3 years

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass

Time frame:From baseline (day 0) to 1.5 and 3 years

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA)

Time frame:From baseline (day 0) to 1.5 and 3 years

Visceral fat, change

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in HbA1c

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change in high sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

percent change from baseline, improvement

componentsALT, change, Total cholesterol, change, HDL-C, change, LDL-C, change, VLDL, change, Triglycerides, change

Secondary/protocol endpoint

Change in systolic and diastolic blood pressure

Time frame:From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint/low confidence

Tapering to zero dose

Time frame:From 1.5 years to 3 years

event count, descriptive

Secondary/protocol endpoint

Serious Adverse Event (SAE)

Time frame: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)

Serious AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Time/dose steps before ending dose tapering

Time frame:From 1.5 years to 3 years

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.