A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (NCT06075667)
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (12 items).
Location: CenExel iResearch, LLC β Decatur, Georgia
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (33 Sites)
- CenExel iResearch, LLC β Decatur, Georgia
- Solaris Clinical Research β Meridian, Idaho
- Cotton O'Neil Diabetes & Endocrinology β Topeka, Kansas
- Pennington Biomedical Research Center β Baton Rouge, Louisiana
- Barry J. Reiner, MD, LLC β Baltimore, Maryland
- M Health Fairview - Delaware Clinical Research Unit (DCRU) β Minneapolis, Minnesota
- Washington University School of Medicine β St Louis, Missouri
- Aventiv Research Inc β Columbus, Ohio
- PriMED Clinical Research β Dayton, Ohio
- Vanderbilt Health One Hundred Oaks β Nashville, Tennessee
- Alberta Diabetes Institute β Edmonton, Alberta
- The Wharton Medical Clinic Clinical Trials Inc β Hamilton, Ontario
- The Hospital for Sick Children β Toronto, Ontario
- CIUSSS- saguenay-Lac-Saint-Jean β Chicoutimi, Quebec
- ReFit Clinic β Olomouc, Olomouc Region
- Nemocnice AGEL Ostrava - Vitkovice a.s. β Ostrava, Ostrava MΔsto
- Fakultni nemocnice v Motole β Prague, Praha 5
- Nemocnice Jihlava β Jihlava,
- Fakultni nemocnice Kralovske Vinohrady β Prague,
- Yitzhak Shamir Medical Center β Beer Yaacov, Central District
- Schneider Children's Medical Center β Petah Tikva, Central District
- Sheba Medical Center β Ramat Gan, Central District
- Shaare Zedek Medical Center β Jerusalem, Jerusalem
- Emek Medical Center β Afula, Northern District
- Rambam Health Care Campus β Haifa, Northern District
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.