GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 Years to 11 Years) With Obesity

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•Age 6-11

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))

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 IDNCT05696847

Org study ID17370

Secondary IDI8F-MC-GPHVEli Lilly and Company

Timeline

Milestones

Study first posted2023-01-25actual

Study start2023-02-07actual

Primary completion2025-01-16actual

Study completion2025-01-16actual

Last update posted2025-08-26actual

Results first posted2025-08-26actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age6 Years

Maximum age11 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male and female participants with body mass index (BMI) ≥ the 95th percentile for age and sex

•Have failed to achieve adequate weight loss through lifestyle modification in the investigator's opinion

•Female participants only: Determined as prepubertal Tanner Stage 1.

Exclusion criteria

•Change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

•Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity

•Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis; or have other GI disorders

•Have a known clinically significant gastric emptying, have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surger, or have endoscopic or device-based therapy for obesity or have had device removal within the last 6 months.

•Have confirmed type 1 or type 2 diabetes mellitus

•Have a history or current cerebrovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IP; or may interfere with the interpretation of data

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints

Primary/registry result

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)

Time frame:Baseline through Week 14

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

Group	Value (number), Percentage of participants	95% CI
Cohort 1: Placebo (BW >=50 kg)TEAE	0.0	—
SAE	0.0	—
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)TEAE	83.3	—
SAE	0.0	—
Cohort 2: Placebo (BW <50 kg)TEAE	0.0	—
SAE	0.0	—
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)TEAE	85.7	—
SAE	0.0	—
Cohort 3: Placebo (BW 40 to 60 kg)TEAE	33.3	—
SAE	0.0	—
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)TEAE	100.0	—
SAE	0.0	—

Primary/protocol endpoint

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)

Time frame:Baseline through Week 14

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide

Time frame:Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.

concentration, descriptive

Posted result

Group	Value (mean), nanogram hour per milliliter (ngh/mL)	95% CI
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)	105000	—
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)	80800	—
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)	156000	—

Secondary/registry result

PK: Maximum Concentration (Cmax) of Tirzepatide

Time frame:Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.

Cmax

concentration, descriptive

Posted result

Group	Value (mean), nanograms per milliliter (ng/mL)	95% CI
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)	884	—
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)	674	—
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)	1280	—

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide

Time frame:Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of Tirzepatide

Time frame:Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6.

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.