Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Orforglipron for obesity?
Research shows that Orforglipron, a drug taken by mouth, helped people with obesity lose weight over 26 weeks. This drug works by activating a specific receptor in the body that can help reduce weight.
12345Is orforglipron safe for humans?
Orforglipron has been studied for safety in people with type 2 diabetes and obesity. In these studies, it was generally well-tolerated, meaning most people did not experience serious side effects.
12345What makes the drug Orforglipron unique for treating obesity?
Orforglipron is unique because it is an oral, non-peptide drug that targets the GLP-1 receptor, which is different from many other obesity treatments that are injectable. This makes it more convenient for patients who prefer taking a pill over injections.
12345Eligibility Criteria
Adolescents with obesity, or overweight with related health issues like hypertension or type 2 diabetes, who've tried losing weight through diet and exercise without success. They must have a BMI in the top percentiles for their age and sex. Those who've lost significant weight recently, plan to undergo bariatric surgery, or have conditions causing secondary obesity can't participate.Inclusion Criteria
I tried and failed to lose enough weight with a diet and exercise program for 3 months.
I am overweight or obese according to CDC guidelines and have a related health issue.
Exclusion Criteria
I or my family have a history of medullary thyroid cancer or MEN2.
I have not started puberty.
I have type 1 diabetes or have had ketoacidosis or a hyperosmolar state.
I have lost more than 11 pounds in the last 3 months.
My obesity is due to a specific medical condition.
I have had or plan to have surgery to help me lose weight.
Participant Groups
The trial is testing Orforglipron against a placebo to see if it helps adolescents lose weight safely over an 18-month period. It will also look at how the body processes the drug.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OrforglipronExperimental Treatment1 Intervention
Participants will receive orforglipron orally
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
MedPharmics, LLCGulfport, MS
Carey Chronis MD Pediatric, Infant and Adolescent MedicineVentura, CA
Yale School of Medicine - Yale Diabetes Center (YDC)) TrialsNew Haven, CT
Stamford Therapeutics ConsortiumStamford, CT
More Trial Locations
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
References
Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. [2023]Orforglipron, an oral, non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist, is in development for type 2 diabetes and obesity. We assessed the efficacy and safety of orforglipron versus placebo or dulaglutide in participants with type 2 diabetes.
Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. [2023]To report the results of a Phase 1b trial evaluating the safety, pharmacokinetics and pharmacodynamics of orforglipron (LY3502970), an oral, non-peptide glucagon-like peptide-1 receptor agonist (GLP-1RA), in patients with type 2 diabetes (T2D).
In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. [2023]Label="SOURCE CITATION">Wharton S, Blevins T, Connery L, et al; GZGI investigators. Daily oral GLP-1 receptor agonist orforglipron for adults with obesity. N Engl J Med. 2023;389:877-880. 37351564.
Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. [2023]Obesity is a major risk factor for many leading causes of illness and death worldwide. Data are needed regarding the efficacy and safety of the nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist orforglipron as a once-daily oral therapy for weight reduction in adults with obesity.
LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. [2022]Treating hyperglycaemia and obesity in individuals with type 2 diabetes using multi-receptor agonists can improve short-term and long-term outcomes. LY3437943 is a single peptide with agonist activity for glucagon, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-1) receptors that is currently in development for the treatment of type 2 diabetes and for the treatment of obesity and associated comorbidities. We investigated the safety, pharmacokinetics, and pharmacodynamics of multiple weekly doses of LY3437943 in people with type 2 diabetes in a 12-week study.