Recruiting
Phase 3

Orforglipron

Sponsor:

Eli Lilly and Company

Code:

NCT06672939

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Study ID

NCT06672939

Start date

Nov 18, 2024

Status verified date

Jul, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orforglipron

Participants will receive orforglipron orally

placebo comparator: Placebo

Participants will receive placebo orally

Interventions

Orforglipron

Administered orally

Placebo

Administered orally

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

MedPharmics, LLC

Recruiting

Gulfport, Mississippi, United States, 39503-2637

Contacts

(228) 206-1283

Principal Investigator:

Paul Matherne

Velocity Clinical Research, Salt Lake City

Recruiting

South Jordan, Utah, United States, 84088

Principal Investigator:

Barbara Rizzardi

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.