Current partner codePEPTIDESDE
NCT06075667·Phase 3·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 3

Enrollment

160

Locations

33

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Oct 10, 2023

  2. Study start

    Oct 16, 2023

  3. Primary completion

    Jun 2, 2026

  4. Study completion

    Jul 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jun 29, 2026

Outcomes

What the study measures.

Primary outcomes

Percent Change from Baseline in Body Mass Index (BMI)

Time frame · Baseline, Week 72

Secondary outcomes

Percentage of Participants with ≥5% BMI Reduction

Time frame · Baseline, Week 72

Change from Baseline in Body Weight

Time frame · Baseline, Week 72

Change from Baseline in Waist Circumference

Time frame · Baseline, Week 72

Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score

Time frame · Baseline, Week 72

Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts

Time frame · Baseline, Week 72

Change from Baseline in Systolic Blood Pressure

Time frame · Baseline, Week 72

Change from Baseline in Diastolic Blood Pressure

Time frame · Baseline, Week 72

Percent Change from Baseline in Total Cholesterol

Time frame · Baseline, Week 72

Change from Baseline in Fasting Glucose

Time frame · Baseline, Week 72

Change from Baseline in Fasting Insulin

Time frame · Baseline, Week 72

Eligibility

Who can take part.

Minimum age
12 Years
Maximum age
17 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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% Exclusion Criteria: * 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.

Study locations

33 registered sites.

Canada · Czechia · Israel · Italy · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.