A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Официальное название

Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)

Обзор

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months. Participants who have completed the primary PW01 study (including the 4-week safety follow-up period) will have the opportunity to receive an additional 156 weeks of treatment with orforglipron as well as continuing the lifestyle intervention.

Вмешательства

• Препарат Orforglipron
  Administered orally
• Препарат Placebo
  Administered orally

Первичные конечные точки

• Percent Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 72]

Вторичные конечные точки (12)

• Change from Baseline in BMI [Срок оценки: Baseline, Week 72]
• Change from Baseline in Body Weight [Срок оценки: Baseline, Week 72]
• Change from Baseline in Waist Circumference [Срок оценки: Baseline, Week 72]
• Change from Baseline in Body Weight Percentile [Срок оценки: Baseline, Week 72]
• Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores [Срок оценки: Baseline, Week 72]
• Change from Baseline in Systolic Blood Pressure [Срок оценки: Baseline, Week 72]
• Change from Baseline in Diastolic Blood Pressure [Срок оценки: Baseline, Week 72]
• Percent Change from Baseline in Total Cholesterol [Срок оценки: Baseline, Week 72]
• Change from Baseline in Fasting Glucose [Срок оценки: Baseline, Week 72]
• Percent Change from Baseline in Fasting Insulin [Срок оценки: Baseline, Week 72]
• Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA) [Срок оценки: Baseline, Week 72]
• Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron [Срок оценки: Baseline, Week 72]

Критерии участия

Критерии включения

J4M-MC-PWMP

• Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
• Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR
• 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 (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,

• hypertension
• type 2 diabetes (T2D)
• prediabetes
• dyslipidemia
• obstructive sleep apnea
• metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)

Критерии исключения

J4M-MC-PW01

• Prepubertal (Tanner stage 1)
• Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening

J4M-MC-PWMP

• 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.
• Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.
• Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
• Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening.
• Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Carey Chronis MD Pediatric, Infant and Adolescent Medicine — Ventura
• Stamford Therapeutics Consortium — Stamford
• Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• Velocity Clinical Research — Lafayette
• MedPharmics, LLC — Gulfport
• Sundance Clinical Research — St Louis
• Lucas Research, Inc. — Morehead City
• … и ещё 6 центров

Япония · 9 центров

• Saitama Medical University Hospital — Iruma-Gun
• Isesaki Municipal Hospital — Isesaki-shi
• University Hospital,Kyoto Prefectural University of Medicine — Kawaramachidori, Kamigyo-ku, Kyoto-city
• Tokyo Medical Center — Meguro-Ku
• Shiga General Hospital — Moriyama
• Nara Prefecture General Medical Center — Nara
• Osaka City General Hospital — Osaka
• Sagaekiminami Clinic — Saga
• … и ещё 1 центр

Великобритания · 5 центров

• Barnsley Hospital NHS Foundation Trust — Barnsley
• Addenbrookes Hospital — Cambridge
• Ninewells Hospital — Dundee
• Northwick Park Hospital — Harrow
• Hull Royal Infirmary — Hull

Польша · 4 центра

• Krakowskie Centrum Medyczne - FutureMeds — Krakow
• FutureMeds - Targowek — Warsaw
• Instytut Diabetologii - Warsaw — Warszewo
• FutureMeds sp. z o. o. — Wroclaw

Израиль · 3 центра

• Shamir Medical Center — Beer Jacob
• Shaare Zedek Medical Center — Jerusalem
• Sheba Medical Center — Ramat Gan

Италия · 3 центра

• Azienda Ospedaliero Universitaria Meyer — Florence
• Azienda Ospedaliero Universitaria Maggiore della Carità — Novara
• Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento — Verona

Идентификаторы

NCT: NCT06672939 · 18868 · J4M-MC-PW01 · J4M-MC-PWMP Master Protocol · 2024-514081-40-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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