Tests orforglipron pill against placebo in teens with obesity or overweight
Tests a once-daily oral orforglipron pill versus placebo in adolescents with obesity or overweight.
Plain-language title generated from the registry record
Registry title: A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Key facts
- Where
- Florence, Novara, Rome, and Verona, ItalySee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT06672939, who can take part
Where in Italy
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyNo longer taking part
- Ospedale Pediatrico Bambino GesùRome, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06672939EU 2024-514081-40-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)
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.
Inclusion: 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: 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 a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2; Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening; J4M-MC-PW01; Prepubertal (Tanner stage 1).