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

What Was Tested

The trial (phase 3) is built around Orforglipron (Foundayo, non-peptide).

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.

It had two arms (groups): Orforglipron (experimental) and Placebo (placebo comparator).

Participants will receive orforglipron orally.

Participants will receive placebo orally.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 12 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Type 2 diabetes (T2D). Obstructive sleep apnea. Metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD).

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: prepubertal (tanner stage 1); gastric bypass; sleeve gastrectomy.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Orforglipron (Foundayo, non-peptide) group and the comparison group should start out alike.

The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Orforglipron (Foundayo, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2024-11-18 with completion listed for 2027-12.

It ran at 34 sites in United States (12), Japan (9), Poland (4), Israel (3), Italy (3) and United Kingdom (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in Body Mass Index (BMI) (time frame: Baseline, Week 72).

It also tracked 12 secondary outcomes, for example Change from Baseline in BMI, Change from Baseline in Body Weight, Change from Baseline in Waist Circumference, Change from Baseline in Body Weight Percentile, Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores and Change from Baseline in Systolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 150 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.