A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2025-06-27
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).

• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

• Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

• either diet/exercise alone or

• up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

• Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.

• Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.

• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).

• Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.

• Have had a history of chronic or acute pancreatitis.