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Clinical Trials List

Protocol NumberI8F-MC-GPIX

NCT Number(ClinicalTrials.gov Identfier)NCT06439277

Active

2024-05-01 - 2028-12-31

Phase III

Recruiting4

ICD-10E66.09

Other obesity due to excess calories

ICD-10E66.1

Drug-induced obesity

ICD-10E66.8

Other obesity

ICD-10E66.9

Obesity, unspecified

ICD-9278.00

Obesity unspecified

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/18

Investigators and Locations

Principal Investigator YEN-HSUAN NI Division of Pediatrics

National Taiwan University Hospital

Co-Principal Investigator

張凱琪 Division of Pediatrics

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Wei Lai Division of Pediatrics

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

陳建彰 Division of Pediatrics
Gigin Lin Division of Radiology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator An-Chyi Chen Division of Pediatrics

China Medical University Hospital

Co-Principal Investigator

Chung-Hsing Wang Division of Pediatrics

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yen-Yin Chou

National Taiwan University Hospital

Co-Principal Investigator

Yu Wen Pan Division of Pediatrics
蔡孟哲 Division of Pediatrics

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Obesity

Objectives

The primary objective of this trial is to further understand Eli Lilly's investigational drug, tirzepatide (LY3298176), an experimental treatment for childhood obesity or overweight. This trial aims to understand: • Whether tirzepatide can control weight in obese adolescents and those with related conditions • Whether tirzepatide is more effective than a placebo • What are the possible side effects?

Test Drug

Prefilled Injectable

Active Ingredient

2406003400

Dosage Form

230

Dosage

2.5MG、5MG、7.5MG、10MG、12.5MG、15MG

Endpoints

- Demonstrated superiority of tirzepatide's maximum tolerated dose (MTD) over placebo in achieving BMI reduction.

- Demonstrated superiority of tirzepatide's maximum tolerated dose (MTD) over placebo in improving weight-related comorbidities.

Inclution Criteria

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

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

The Estimated Number of Participants

Taiwan

32 participants
Global

300 participants