GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 3

A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

150

estimated

Study population

Obesity / overweight

Key I/E criterion

•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 IDNCT06672939

Org study ID18868

Secondary ID2024-514081-40-00

Secondary IDJ4M-MC-PW01Eli Lilly and Company

Secondary IDJ4M-MC-PWMP Master ProtocolEli Lilly and Company

Timeline

Milestones

Study first posted2024-11-04actual

Study start2024-11-18actual

Last update posted2026-05-27actual

Primary completion2027-12estimated (month precision)

Study completion2031-01estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

J4M-MC-PWMP

•Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.

•Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart [CDC-NCHS, 2022]); OR

•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 (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,

–hypertension

–type 2 diabetes (T2D)

–prediabetes

–dyslipidemia

–obstructive sleep apnea

–metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)

Exclusion criteria

J4M-MC-PW01

•Prepubertal (Tanner stage 1)

•Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening

J4M-MC-PWMP

•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.

•Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.

•Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.

•Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening.

•Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

Endpoints (13)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

6 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

Change from Baseline in BMI

Time frame:Baseline, Week 72

BMI, change

change from baseline, 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

Time frame:Baseline, Week 72

change from baseline, 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

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

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 72

percent 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 Total and Domain Scores

Time frame:Baseline, Week 72

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline, 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.