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New treatment option for Obesity
Official title A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
ClinicalTrials.gov ID: NCT06672939
What this study is testing
What is Orforglipron?
Orforglipron is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for obesity.
Also referred to as LY3502970.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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...
- 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...
- hypertension
You likely can't join if
- 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...
- Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
- gastric bypass
- sleeve gastrectomy
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ventura, California, United States
- Stamford, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lafayette, Louisiana, United States
- Gulfport, Mississippi, United States
- St Louis, Missouri, United States
- Morehead City, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Tomball, Texas, United States
- South Jordan, Utah, United States
- Beer Jacob, Israel
- Jerusalem, Israel
- Ramat Gan, Israel
- Florence, Italy
- Novara, Italy
- Verona, Italy
- Iruma-Gun, Japan
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ventura, California, United States; Stamford, Connecticut, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Lafayette, Louisiana, United States; Gulfport, Mississippi, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.