Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT05696847Other id17370Other idI8F-MC-GPHV

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 28 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 7 Feb 2023
Primary completion: 16 Jan 2025
Completion: 16 Jan 2025
First posted: 25 Jan 2023
Last update posted: 26 Aug 2025
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 1
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
NCT05696847
7 Feb 2023 to 16 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to evaluate the safety and tolerability of tirzepatide (LY3298176) in pediatric participants with obesity. The blood tests will be performed to investigate how the body processes the study drug in these participants. For each participant, the study will last about approximately 13 weeks excluding the screening period.

Interventions

TirzepatideDrug
PlaceboDrug

Arms6

Placebo comparator
Cohort 1: Placebo (BW >=50 kg)
Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.
Experimental
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
Placebo comparator
Cohort 2: Placebo (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.
Experimental
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)
Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8.
Placebo comparator
Cohort 3: Placebo (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8.
Experimental
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
Time frame · Baseline through Week 14
Registry description
Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record.

Secondary outcomes(2)

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.
Registry description
PK: AUC0-tau of tirzepatide was reported.
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.
Registry description
PK: Cmax of tirzepatide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline through Week 14

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

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

Secondary and other outcome results(2)

Secondary outcomeMean· 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.

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

Group	Value (nanogram hour per milliliter (ngh/mL))	Spread
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)	105000	33100
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)	80800	9580
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)	156000	22500

Secondary outcomeMean· 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.

PK: Maximum Concentration (Cmax) of Tirzepatide

Group	Value (nanograms per milliliter (ng/mL))	Spread
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)	884	243
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)	674	63.8
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)	1280	194

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Cohort 1: Placebo (BW >=50 kg)Participants in this cohort had a screening body weight of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) in Weeks 1 to 8.	0 / 2	0 / 2	0 / 2
Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW in Weeks 1 to 4 followed by 5 mg tirzepatide in Weeks 5 to 8.	0 / 6	0 / 6	5 / 6
Cohort 2: Placebo (BW <50 kg)Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW in Weeks 1 to 8.	0 / 2	0 / 2	0 / 2
Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW in Weeks 1 to 4 followed by 2.5 mg tirzepatide in Weeks 5 to 8.	0 / 7	0 / 7	6 / 7
Cohort 3: Placebo (BW 40 to 60 kg)Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW in Weeks 1 to 8.	0 / 3	0 / 3	1 / 3
Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW in Weeks 1 to 4 followed by 5 mg tirzepatide in Weeks 5 to 8.	0 / 7	0 / 7	7 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 6 Years up to 11 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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