A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

JRCT ID: jRCT2051240207

Registered date:09/12/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Obesity
Overweight

• Date of first enrollment: 21/01/2025
• Target sample size: 125
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

DRUG: Orforglipron(Other Name: LY3502970)
Administered orally. ISA specific interventions will be listed in the ISA.
DRUG: Placebo
Administered orally. ISA specific interventions will be listed in the ISA.

[Study Arms]
Experimental: Orforglipron (ISA PW01)
Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
Interventions:
Drug: Orforglipron
Drug: Placebo

Outcome(s)

• Primary Outcome: Number of Participants Allocated to Each ISA [ Time Frame: Baseline to Week 72

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

- 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
- Applies to participant age between 12 and <18 years old. 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)

Exclude criteria

- 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-BandR 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 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 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06672549