Phase 1 · Tirzepatide

NCT05696847 trial results

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

Participants: 28
Status: completed
Completed: 2025-01-16
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05696847), updated at source Aug 26, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT05696847 measured first

Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)Percentage of participants · Baseline through Week 14 · number

Measure	Cohort 1: Placebo (BW >=50 kg)n=2	Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)n=6	Cohort 2: Placebo (BW <50 kg)n=2	Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)n=7	Cohort 3: Placebo (BW 40 to 60 kg)n=3	Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)n=7
TEAE	0.0	83.3	0.0	85.7	33.3	100.0
SAE	0.0	0.0	0.0	0.0	0.0	0.0

Side effects by arm

Side effects in NCT05696847

Percent of participants affected, Baseline Up To 14 Weeks. The most common events the registry lists.

Event	Cohort 1: Placebo (BW >=50 kg)	Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)	Cohort 2: Placebo (BW <50 kg)	Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)	Cohort 3: Placebo (BW 40 to 60 kg)	Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)
Any serious event	0%	0%	0%	0%	0%	0%
Vomiting	0%	16.7%	0%	14.3%	0%	85.7%
Nausea	0%	50%	0%	28.6%	0%	71.4%
Abdominal pain	0%	0%	0%	14.3%	33.3%	57.1%
Decreased appetite	0%	50%	0%	14.3%	0%	14.3%
Diarrhoea	0%	16.7%	0%	0%	0%	42.9%
Constipation	0%	33.3%	0%	0%	33.3%	0%
Pyrexia	0%	0%	0%	14.3%	33.3%	0%
Pneumonia	0%	0%	0%	0%	33.3%	0%
Headache	0%	0%	0%	14.3%	33.3%	0%
Dyspepsia	0%	0%	0%	0%	0%	14.3%
Eructation	0%	0%	0%	0%	0%	14.3%
Flatulence	0%	0%	0%	14.3%	0%	0%
Gastrooesophageal reflux disease	0%	0%	0%	14.3%	0%	0%
Fatigue	0%	0%	0%	14.3%	0%	0%
Injection site erythema	0%	0%	0%	0%	0%	14.3%
Injection site reaction	0%	0%	0%	14.3%	0%	0%
Gastroenteritis	0%	0%	0%	14.3%	0%	0%
Otitis media	0%	0%	0%	14.3%	0%	0%
Urinary tract infection	0%	0%	0%	0%	0%	14.3%
Hypoglycaemia	0%	0%	0%	0%	0%	14.3%
Myalgia	0%	0%	0%	14.3%	0%	0%
Pain in extremity	0%	0%	0%	14.3%	0%	0%
Dizziness	0%	0%	0%	14.3%	0%	0%
Pollakiuria	0%	0%	0%	14.3%	0%	0%
Cough	0%	0%	0%	14.3%	0%	0%

Secondary outcomes

What else it measured

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatidenanogram *hour per milliliter (ng*h/mL) · 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. · mean

Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)n=6	Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)n=7	Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)n=7
105000(33100)	80800(9580)	156000(22500)

PK: Maximum Concentration (Cmax) of Tirzepatidenanograms per milliliter (ng/mL) · 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. · mean

Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg)n=6	Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg)n=7	Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg)n=7
884(243)	674(63.8)	1280(194)

The trial

How NCT05696847 was run

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.

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.
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.
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.
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.
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.
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.

Who could join the trial

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

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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