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NCT06075667Active, not recruitingPhase 3

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

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
160 (actual)
First submitted
4 Oct 2023
Start date
16 Oct 2023
Primary completion date
2 Jun 2026
Lead sponsor
Eli Lilly and Company
Diseases
Obesity
NCT number
NCT06075667
EU CT number
2023-504413-80-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 160
  • From 16 Oct 2023 to the primary completion date, 2 Jun 2026
  • 31 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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.
  • 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.

Other illness

  • Have Type 1 Diabetes
  • 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.

Other

  • Are prepubertal (Tanner stage 1).

Who the study is looking for

  • 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%

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIUSSS- saguenay-Lac-Saint-Jean
Coordinator of this site? Confirm its status
ChicoutimiCanadaUnknown status
Alberta Diabetes Institute
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EdmontonCanadaUnknown status
The Wharton Medical Clinic Clinical Trials Inc
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
The Hospital for Sick Children
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Nemocnice Jihlava prispevkova organizace
Coordinator of this site? Confirm its status
Jihlava 1CzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaActive, not recruiting
Emek Medical Center
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AfulaIsraelUnknown status
Soroka Medical Center
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BeershebaIsraelUnknown status
Yitzhak Shamir Medical Center
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Beer YaacovIsraelUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Schneider Children's Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyActive, not recruiting
Università degli Studi di Messina
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MessinaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyActive, not recruiting
Universita' Degli Studi Di Verona
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VeronaItalyActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandActive, not recruiting
Instytut Diabetologii.sp.z.o.o.
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WarsawPolandActive, not recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandActive, not recruiting
Barry J. Reiner, MD, LLC
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BaltimoreUnited StatesUnknown status
Pennington Biomedical Research Center
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Baton RougeUnited StatesUnknown status
Aventiv Research Inc
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ColumbusUnited StatesUnknown status
Primed Clinical Research
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DaytonUnited StatesUnknown status
CenExel iResearch, LLC
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DecaturUnited StatesUnknown status
Solaris Clinical Research
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MeridianUnited StatesUnknown status
M Health Fairview - Delaware Clinical Research Unit (DCRU)
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MinneapolisUnited StatesUnknown status
Vanderbilt Health One Hundred Oaks
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NashvilleUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Cotton O'Neil Diabetes & Endocrinology
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TopekaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.