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

Phase 3

Recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT06672939
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2024-11-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2027-02
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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)

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Exclusion Criteria

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron	Orforglipron	Participants will receive orforglipron orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Mass Index (BMI)	Baseline, Week 72

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in BMI	Baseline, Week 72
Change from Baseline in Body Weight	Baseline, Week 72
Change from Baseline in Waist Circumference	Baseline, Week 72
Change from Baseline in Body Weight Percentile	Baseline, Week 72	Based on sex- and age-specific growth charts
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores	Baseline, Week 72	The IWQOL-Kids is a validated, 27-item, patient reported outcomes instrument that assesses weight-related quality of life for youth aged 11 to 19 years in 4 domains: * physical comfort (6 items); * body esteem (9 items); * social life (6 items), and; * family relations (6 items). It has a recall period of "the past 7 days." All items are rated on a 5-point truth scale ("always true" to "never true"). The 4-domain scores and total score range from 0 to 100, with higher scores indicating better quality of life.
Change from Baseline in Systolic Blood Pressure	Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure	Baseline, Week 72
Percent Change from Baseline in Total Cholesterol	Baseline, Week 72
Change from Baseline in Fasting Glucose	Baseline, Week 72
Percent Change from Baseline in Fasting Insulin	Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)	Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron	Baseline, Week 72

Trial Locations

Locations (34)

Carey Chronis MD Pediatric, Infant and Adolescent Medicine; 🇺🇸 Ventura, California, United States

Yale School of Medicine - Yale Diabetes Center (YDC)) Trials; 🇺🇸 New Haven, Connecticut, United States

Stamford Therapeutics Consortium; 🇺🇸 Stamford, Connecticut, United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics; 🇺🇸 Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Sundance Clinical Research; 🇺🇸 Saint Louis, Missouri, United States

CPQuali Pesquisa Clínica; 🇧🇷 Sao Paulo, Brazil

Sheba Medical Center; 🇮🇱 Ramat Gan, HaMerkaz, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Yerushalayim, Israel

Shamir Medical Center; 🇮🇱 Beer Jacob, Israel

Shikoku Medical Center for Children and Adults; 🇯🇵 Zentsuji, Kagawa, Japan

Saitama Medical University Hospital; 🇯🇵 Iruma-Gun, Saitama, Japan

Osaka City General Hospital; 🇯🇵 Osaka, Japan

Velocity Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Lucas Research, Inc.; 🇺🇸 Morehead City, North Carolina, United States

Childrens Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vanderbilt Health One Hundred Oaks; 🇺🇸 Nashville, Tennessee, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research; 🇺🇸 Houston, Texas, United States

La Providence Pediatrics Clinic - Chemidox Clinical Trials; 🇺🇸 Houston, Texas, United States

Martin Diagnostic Clinic; 🇺🇸 Tomball, Texas, United States

Velocity Clinical Research, Salt Lake City; 🇺🇸 South Jordan, Utah, United States

L2IP - Instituto de Pesquisas Clínicas; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital Universitario de Caxias do Sul; 🇧🇷 Caxias do Sul, Rio Grande Do Sul, Brazil

Sagaekiminami Clinic; 🇯🇵 Saga-shi, Japan

PanAmerican Clinical Research S.A.de C.V. Guadalajara; 🇲🇽 Guadalajara, JA, Mexico

Hospital Angeles Puebla; 🇲🇽 Puebla, Mexico

Bristol Royal Hospital for Children; 🇬🇧 Bristol, Bristol, City Of, United Kingdom

Addenbrookes Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Hull Royal Infirmary; 🇬🇧 Hull, East Riding Of Yorkshire, United Kingdom

Northwick Park Hospital; 🇬🇧 Harrow, Middlesex, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, Scotland, United Kingdom

Barnsley Hospital NHS Foundation Trust; 🇬🇧 Barnsley, United Kingdom

Alder Hey Children's Hospital; 🇬🇧 Liverpool, United Kingdom

MedPharmics, LLC; 🇺🇸 Gulfport, Mississippi, United States