A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Purpose

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX 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.

Conditions

  • Obesity
  • Weight Gain

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia. - Have history of at least 1 self-reported unsuccessful dietary effort to lose weight. - Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion Criteria

  • Have undergone or plan to undergo a 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. - Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records - Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state - Have type 2 diabetes or have a HbA1c > 6.4% at screening - Have a history of chronic or acute pancreatitis - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide 		Participants will receive tirzepatide subcutaneously (SC).
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo 		Participants will receive placebo SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento 5389489, California 5332921 95821
Contact:
916-426-1902

Nemours Children's Health - Delaware
Wilmington 4145381, Delaware 4142224 19803
Contact:
302-651-5965

CenExel iResearch, LLC
Decatur 4191124, Georgia 4197000 30030
Contact:
404-537-1281

Medical Research Partners
Ammon 5583997, Idaho 5596512 83406
Contact:
208-681-9070

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
Contact:
312-227-6090

Indiana University Health University Hospital
Indianapolis 4259418, Indiana 4921868 46202
Contact:
317-607-9083

UBMD Pediatrics
Buffalo 5110629, New York 5128638 14203
Contact:
716-323-0170

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
Contact:
315-464-9006

Driscoll Children's Hospital
Corpus Christi 4683416, Texas 4736286 78411
Contact:
361-739-7250

Epic Medical Research - DeSoto
DeSoto 4685524, Texas 4736286 75115
Contact:
197-277-7695

Valley Institute of Research - Fort Worth
Fort Worth 4691930, Texas 4736286 76164
Contact:
817-625-7733

Consano Clinical Research, LLC
Shavano Park 4728147, Texas 4736286 78231
Contact:
210-545-4900

Texas Valley Clinical Research
Weslaco 4740629, Texas 4736286 78596
Contact:
956-431-8090

Alliance for Multispecialty Research, LLC
Layton 5777107, Utah 5549030 84041

University Pediatric Hospital
San Juan 4568127, Puerto Rico 00935
Contact:
17876142159

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Detailed Description

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.