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Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT06672939 (opens ClinicalTrials.gov in a new tab)Other id18868Other idJ4M-MC-PW01Other idJ4M-MC-PWMP Master ProtocolOther id2024-514081-40-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
150 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
6 countries

United States, Israel, Italy, Japan, Poland, United Kingdom

Start
18 Nov 2024
Primary completion
Dec 2027 (estimated)
Completion
Jan 2031 (estimated)
First posted
4 Nov 2024
Last update posted
24 Aug 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242026202820302032
  1. Ph 3

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

    NCT06672939

    18 Nov 2024 to est. Jan 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms2

  • Experimental

    Orforglipron

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo

    Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Mass Index (BMI)

    Time frame · Baseline, Week 72

Secondary outcomes(12)

  1. Change from Baseline in BMI

    Time frame · Baseline, Week 72

  2. Change from Baseline in Body Weight

    Time frame · Baseline, Week 72

  3. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 72

  4. Change from Baseline in Body Weight Percentile

    Time frame · Baseline, Week 72

    Registry description

    Based on sex- and age-specific growth charts

  5. Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores

    Time frame · Baseline, Week 72

    Registry description

    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.

  6. Change from Baseline in Systolic Blood Pressure

    Time frame · Baseline, Week 72

  7. Change from Baseline in Diastolic Blood Pressure

    Time frame · Baseline, Week 72

  8. Percent Change from Baseline in Total Cholesterol

    Time frame · Baseline, Week 72

  9. Change from Baseline in Fasting Glucose

    Time frame · Baseline, Week 72

  10. Percent Change from Baseline in Fasting Insulin

    Time frame · Baseline, Week 72

  11. Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)

    Time frame · Baseline, Week 72

  12. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron

    Time frame · Baseline, Week 72

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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) 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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