Clinical trial

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

Recruiting now · Phase 3 · 6 countries · Registry ID NCT06672939

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

Orforglipron

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

Percent Change from Baseline in Body Mass Index (BMI)Baseline, Week 72

Study locations

34 locations were listed when this page was built. The first 40 are shown.

Shamir Medical Center🇮🇱 Beer Jacob, Israel
Shaare Zedek Medical Center🇮🇱 Jerusalem, Israel
Sheba Medical Center🇮🇱 Ramat Gan, Israel
Azienda Ospedaliero Universitaria Meyer🇮🇹 Florence, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità🇮🇹 Novara, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento🇮🇹 Verona, Italy
Saitama Medical University Hospital🇯🇵 Iruma-Gun, Japan
Study contactContact
Toru KikuchiPrincipal Investigator
Isesaki Municipal Hospital🇯🇵 Isesaki-shi, Japan
Study contactContact
Yoko TakanoPrincipal Investigator
University Hospital,Kyoto Prefectural University of Medicine🇯🇵 Kawaramachidori, Kamigyo-ku, Kyoto-city, Japan
Study contactContact
Satoru SugimotoPrincipal Investigator
Tokyo Medical Center🇯🇵 Meguro-Ku, Japan
Study contactContact
Masashi MiharuPrincipal Investigator
Shiga General Hospital🇯🇵 Moriyama, Japan
Study contactContact
Katsuyuki MatsuiPrincipal Investigator
Nara Prefecture General Medical Center🇯🇵 Nara, Japan
Study contactContact
Sayaka YoshidaPrincipal Investigator
Osaka City General Hospital🇯🇵 Osaka, Japan
Study contactContact
Jun MoriPrincipal Investigator
Sagaekiminami Clinic🇯🇵 Saga, Japan
Study contactContact
Tateo KunoPrincipal Investigator
Shikoku Medical Center for Children and Adults🇯🇵 Zentsujichó, Japan
Study contactContact
Takafumi OkadaPrincipal Investigator
Krakowskie Centrum Medyczne - FutureMeds🇵🇱 Krakow, Poland
FutureMeds - Targowek🇵🇱 Warsaw, Poland
Instytut Diabetologii - Warsaw🇵🇱 Warszewo, Poland
FutureMeds sp. z o. o.🇵🇱 Wroclaw, Poland
Barnsley Hospital NHS Foundation Trust🇬🇧 Barnsley, United Kingdom
Ninewells Hospital🇬🇧 Dundee, United Kingdom
Study contactContact
Nicholas ConwayPrincipal Investigator
Hull Royal Infirmary🇬🇧 Hull, United Kingdom
Children's Healthcare of Atlanta - Center for Advanced Pediatrics🇺🇸 Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago🇺🇸 Chicago, Illinois, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research🇺🇸 Houston, Texas, United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials🇺🇸 Houston, Texas, United States
Velocity Clinical Research🇺🇸 Lafayette, Louisiana, United States
Lucas Research, Inc.🇺🇸 Morehead City, North Carolina, United States
Vanderbilt Health One Hundred Oaks🇺🇸 Nashville, Tennessee, United States
Carey Chronis MD Pediatric, Infant and Adolescent Medicine🇺🇸 Oxnard, California, United States
Childrens Hospital of Pittsburgh🇺🇸 Pittsburgh, Pennsylvania, United States
Sundance Clinical Research🇺🇸 St Louis, Missouri, United States
Stamford Therapeutics Consortium🇺🇸 Stamford, Connecticut, United States
Martin Diagnostic Clinic🇺🇸 Tomball, Texas, United States