ObesityPhase 1NCT05696847
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
A Phase 1 study testing Tirzepatide in people with Obesity, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Feb 2023to 16 Jan 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atlanta Center of Medical Research
Atlanta, Georgia, 30331 2012
Baylor College of Medicine
Houston, Texas, 77030
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
About this study
Official title: A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 Years to 11 Years) With Obesity
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.
- Conditions
- Obesity
- Being tested
- Tirzepatide, Placebo
- Keywords
- Pediatrics, Obesity, Chronic weight management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Placebo (BW >=50 kg) | Placebo comparator | 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. Receives: Drug: Placebo |
| Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Experimental | 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. Receives: Drug: Tirzepatide |
| Cohort 2: Placebo (BW <50 kg) | Placebo comparator | Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8. Receives: Drug: Placebo |
| Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Experimental | 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. Receives: Drug: Tirzepatide |
| Cohort 3: Placebo (BW 40 to 60 kg) | Placebo comparator | 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. Receives: Drug: Placebo |
| Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Experimental | 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. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
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.
Measured: Baseline through Week 14
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
PK: AUC0-tau of tirzepatide was reported.
Measured: 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
PK: Cmax of tirzepatide
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start7 Feb 2023
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696847
- Sponsor's protocol ID
- 17370
- Other IDs
- I8F-MC-GPHV
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2023
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No