Clinical trial NCT06672939: A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 125
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, 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.


Eligibility 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.

Primary outcomes:
measure: Percent Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Change from Baseline in BMI
timeFrame: Baseline, Week 72
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 72
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Change from Baseline in Body Weight Percentile
timeFrame: Baseline, Week 72
measure: Change in Impact of Weight on Quality of Life (IWQOL)-Kids Total and Domain Scores
timeFrame: Baseline, Week 72
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: Baseline, Week 72
measure: Change from Baseline in Diastolic Blood Pressure
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 72
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Total Body Fat Mass as Determined by Dual-Energy X-Ray Absorptiometry (DXA)
timeFrame: Baseline, Week 72
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Orforglipron
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Carey Chronis MD Pediatric, Infant and Adolescent Medicine
state: California
city: New Haven
country: United States
facility: Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Lafayette
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Health One Hundred Oaks
state: Tennessee
city: Houston
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Houston
country: United States
facility: La Providence Pediatrics Clinic - Chemidox Clinical Trials
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: South Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Brasília
country: Brazil
facility: L2IP - Instituto de Pesquisas Clínicas
state: Distrito Federal
city: Caxias do Sul
country: Brazil
facility: Hospital Universitario de Caxias do Sul
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Beer Jacob
country: Israel
facility: Shamir Medical Center
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
state: Toscana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
state: Veneto
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Zentsuji
country: Japan
facility: Shikoku Medical Center for Children and Adults
state: Kagawa
city: Iruma-Gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Saga-shi
country: Japan
facility: Sagaekiminami Clinic
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne - FutureMeds
city: Warsow
country: Poland
facility: Instytut Diabetologii - Warsaw
city: Warszawa
country: Poland
facility: FutureMeds - Targowek
city: Wroclaw
country: Poland
facility: FutureMeds sp. z o. o.
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
state: Bristol, City Of
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: East Riding Of Yorkshire
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: