DelfaGLP-1 Atlas

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RecruitingPhase 3

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

73

Recruiting sites

27

Enrollment

300

estimated

Study population

Dyslipidemia, Hypertension, Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criterion

•Age 12-17

Primary endpoints

•BMI, change•A Composite Endpoint of Normalization or Clinically Significant Improvement

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 IDNCT06439277
Org study ID18832
Secondary IDI8F-MC-GPIXEli Lilly and Company

Timeline

Milestones

Study first posted2024-06-03actual
Study start2024-06-03actual
Last update posted2026-05-19actual
Primary completion2027-10estimated (month precision)
Study completion2030-12estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

DyslipidemiaHypertensionObesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
•Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
•Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion criteria

•Have undergone or plan to undergo a 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.
•Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
•Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
•Have type 2 diabetes or have a HbA1c > 6.4% at screening
•Have a history of chronic or acute pancreatitis
•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Endpoints (14)

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
8
Cardiometabolic biomarkers
3
Other clinical outcomes
2
Glycemic / diabetes
1

Weight & body composition

8 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 Who Achieve BMI Reduction of ≥ 5%

Time frame:Week 72

BMI, change

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve BMI Reduction of ≥ 10%

Time frame:Week 72

BMI, change

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve BMI Reduction of ≥ 15%

Time frame:Week 72

BMI, change

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve BMI Reduction of ≥ 20%

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)

Time frame:Baseline, Week 72

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent 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

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

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 (DBP)

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity

Time frame:Baseline, Week 72

composite event, improvement

Secondary/protocol endpoint

Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)

Time frame:Baseline, Week 72

AHI, change

change from baseline, improvement

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.