DelfaGLP-1 Atlas

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Active not recruitingPhase 3

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

33

Recruiting sites

—

Enrollment

150

estimated

Study population

Obesity / overweight

Key I/E criteria

•HbA1c ≤9%•Age 12-17

Primary endpoint

•BMI, change

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 IDNCT06075667
Org study ID17365
Secondary ID2023-504413-80-00EU Trial Number
Secondary IDI8F-MC-GPHPEli Lilly and Company

Timeline

Milestones

Study first posted2023-10-10actual
Study start2023-10-16actual
Last update posted2025-06-25actual
Primary completion2026-05estimated (month precision)
Study completion2029-07estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
•Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
–dyslipidemia
–pre-hypertension
–hypertension
–nonalcoholic fatty liver disease
–obstructive sleep apnea
–prediabetes
–documented preexisting condition of Type 2 Diabetes

Participants with Type 2 Diabetes Mellitus (T2DM)

•Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%

Exclusion criteria

•Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
•Have Type 1 Diabetes
•Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
•Are prepubertal (Tanner stage 1).
•Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
•Have a history of chronic or acute pancreatitis.
•Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to
–gastric bypass
–sleeve gastrectomy
–restrictive bariatric surgery, such as Lap-Band gastric banding, or
–any other procedure intended to result in weight reduction.

Endpoints (12)

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
5
Cardiometabolic biomarkers
3
Glycemic / diabetes
2
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥5% BMI Reduction

Time frame:Baseline, Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts

Time frame:Baseline, Week 72

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 72

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score

Time frame:Baseline, Week 72

IWQOL-Lite physical

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide

Time frame:Baseline through Week 72

AUC₀–∞

concentration, descriptive

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.