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
Sites (31)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIUSSS- saguenay-Lac-Saint-Jean Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| Alberta Diabetes Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| The Wharton Medical Clinic Clinical Trials Inc Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Nemocnice Jihlava prispevkova organizace Coordinator of this site? Confirm its status | Jihlava 1 | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultní Nemocnice Královské Vinohrady Coordinator of this site? Confirm its status | Prague 10 | Czechia | Active, not recruiting |
| Emek Medical Center Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Beer Yaacov | Israel | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Università degli Studi di Messina Coordinator of this site? Confirm its status | Messina | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Active, not recruiting |
| Universita' Degli Studi Di Verona Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Instytut Diabetologii.sp.z.o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Active, not recruiting |
| Barry J. Reiner, MD, LLC Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Aventiv Research Inc Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Primed Clinical Research Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Solaris Clinical Research Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| M Health Fairview - Delaware Clinical Research Unit (DCRU) Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt Health One Hundred Oaks Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.