Recruiting
Phase 3

Tirzepatide

Sponsor:

Eli Lilly and Company

Code:

NCT06439277

Conditions

Obesity

Weight Gain

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Placebo

Study Details

Brief summary:

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Conditions

Obesity

Weight Gain

Study ID

NCT06439277

Start date

Jun 3, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
  • Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
  • Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion Criteria:

  • Have undergone or plan to undergo a 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 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 type 2 diabetes or have a HbA1c > 6.4% at screening
  • Have a history of chronic or acute pancreatitis
  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

Participants will receive tirzepatide subcutaneously (SC).

placebo comparator: Placebo

Participants will receive placebo SC.

Interventions

Tirzepatide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Percent Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
  • A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity [ Time Frame: Baseline, Week 72 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Winterberry Research Inc.

Recruiting

Hamilton, Canada, L8J 0B6

Contacts

365-366-6267

Principal Investigator:

Steven Zizzo

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.