DelfaGLP-1 Atlas

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ADVANCE

RecruitingPhase 3

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

50

Recruiting sites

1

Enrollment

125

estimated

Study population

Obesity / overweight

Key I/E criterion

•Age 6-17

Primary endpoint

•Number of Participants Allocated to Each ISA

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 IDNCT06672549
Org study ID18865
Secondary IDJ4M-MC-PWMPEli Lilly and Company

Timeline

Milestones

Study first posted2024-11-04actual
Study start2024-11-18actual
Last update posted2026-05-19actual
Primary completion2027-02estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age6 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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
•Applies to participant age between 12 and <18 years old. 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

•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 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 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 (1)

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.

Other (unclassified)

1 endpoint
Primary/protocol endpoint

Number of Participants Allocated to Each ISA

Time frame:Baseline to Week 72

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.