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

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Weight Gain; Obesity

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06439277

I8F-MC-GPIX (Other Identifier)

18832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

Participants will receive tirzepatide subcutaneously (SC).

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC.

Treatment:

Drug: Placebo