A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Participants who have completed the primary 72-week GPHP 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.

Key facts

Study ID

NCT06075667

Run by

Eli Lilly and Company

People needed

160

Starts

2023-10-16

Expected to finish

2029-07-01

Last updated by the study team

2026-06-29

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
• Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
• dyslipidemia
• pre-hypertension
• hypertension
• nonalcoholic fatty liver disease
• obstructive sleep apnea
• prediabetes
• documented preexisting condition of Type 2 Diabetes
• Participants with Type 2 Diabetes Mellitus (T2DM)
• Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%

You may not qualify if…

• Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
• Have Type 1 Diabetes
• Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
• Are prepubertal (Tanner stage 1).
• Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
• Have a history of chronic or acute pancreatitis.
• Have undergone or plan to undergo 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.

Where it is running

• CenExel iResearch, LLC — Decatur, Georgia, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Barry J. Reiner, MD, LLC — Baltimore, Maryland, United States
• M Health Fairview - Delaware Clinical Research Unit (DCRU) — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Aventiv Research Inc — Columbus, Ohio, United States
• PriMED Clinical Research — Dayton, Ohio, United States
• Vanderbilt Health One Hundred Oaks — Nashville, Tennessee, United States
• Alberta Diabetes Institute — Edmonton, Alberta, Canada
• The Wharton Medical Clinic Clinical Trials Inc — Hamilton, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada
• CIUSSS- saguenay-Lac-Saint-Jean — Chicoutimi, Quebec, Canada
• ReFit Clinic — Olomouc, Olomouc Region, Czechia
• Nemocnice AGEL Ostrava - Vitkovice a.s. — Ostrava, Ostrava Město, Czechia
• Fakultni nemocnice v Motole — Prague, Praha 5, Czechia
• Nemocnice Jihlava — Jihlava, Czechia
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
• Yitzhak Shamir Medical Center — Beer Yaacov, Central District, Israel
• Schneider Children's Medical Center — Petah Tikva, Central District, Israel
• Sheba Medical Center — Ramat Gan, Central District, Israel
• Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel
• Emek Medical Center — Afula, Northern District, Israel
• Rambam Health Care Campus — Haifa, Northern District, Israel

Full record on ClinicalTrials.gov

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