Date: June 26, 2023

Introduction: Eli Lilly and Company, a leading pharmaceutical firm, has unveiled promising phase 2 data for their investigational molecule, retatrutide, aimed at tackling obesity. The trial demonstrated a mean weight reduction of up to 17.5% (41.2 lb. or 18.7 kg) in adults with obesity or overweight without diabetes at 24 weeks. Additionally, a secondary endpoint revealed an even higher mean weight reduction of up to 24.2% (57.8 lb. or 26.2 kg) at 48 weeks. These exciting results were presented at the American Diabetes Association’s® 83rd Scientific Sessions and published in The New England Journal of Medicine (NEJM).

Key Highlights:

• Eli Lilly’s retatrutide exhibits a remarkable mean weight reduction of up to 17.5% (41.2 lb. or 18.7 kg) in adults with obesity or overweight without diabetes at 24 weeks.
• A secondary endpoint shows a substantial mean weight reduction of up to 24.2% (57.8 lb. or 26.2 kg) at 48 weeks.
• The safety profile of retatrutide is comparable to other incretin-based therapies, with mostly mild-to-moderate gastrointestinal side effects reported during the dose escalation period.
• Longer duration phase 3 trials are planned to further evaluate retatrutide’s potential pharmacotherapeutic benefits for obesity treatment.
• Cardiometabolic measures, including blood pressure, cholesterol levels, HbA1c, and glucose and insulin levels, showed improvement with retatrutide treatment at weeks 24 and 48.

TRIUMPH Phase 3 Clinical Program: Building on the positive phase 2 results, Eli Lilly is gearing up for the TRIUMPH phase 3 clinical program to explore retatrutide’s efficacy and safety for chronic weight management, obstructive sleep apnea (OSA), and knee osteoarthritis (OA) in individuals with obesity and overweight. The program includes four core registration studies catering to different patient populations:

1. TRIUMPH-1: Investigates the efficacy and safety in participants without type 2 diabetes who have obesity or overweight, including those with OSA and OA.
2. TRIUMPH-2: Studies the efficacy and safety in participants with type 2 diabetes who have obesity or overweight, including those with OSA.
3. TRIUMPH-3: Assesses the efficacy and safety in participants with Class II (BMI ≥ 35 kg/m2 and < 40 kg/m2) or Class III (BMI ≥ 40 kg/m2) obesity and established cardiovascular disease.
4. TRIUMPH-4: Evaluates the efficacy and safety in participants with obesity or overweight with OA.

Looking Ahead: The phase 2 data for retatrutide have provided Eli Lilly with confidence to embark on phase 3 trials, which will go beyond weight reduction to comprehensively address obesity and its complications. This research opens doors to potential highly effective treatment options for individuals battling obesity, a treatable yet complex chronic disease.

For more details on the study and retatrutide’s potential, refer to Eli Lilly’s original press release: [Link to original press release]