Prime Highlights
- Eli Lilly reports strong Phase 3 results for retatrutide, targeting an FDA biologics license application in the first quarter of next year.
- The drug shows leading weight loss across multiple patient groups, reinforcing its position within Lilly’s growing cardiometabolic drug portfolio.
Key Facts
- Patients with obesity and heart disease lost 22.6 percent of body weight at the highest dose over 80 weeks.
- Diabetes patients with obesity lost 20.8 percent of body weight and lowered A1C levels by 1.6 percent.
Background
Eli Lilly announced positive results from two more Phase 3 trials of its experimental obesity drug retatrutide and confirmed plans to submit an application to the U.S. Food and Drug Administration in the first quarter of next year.
Retatrutide works by targeting three metabolic hormones, GLP-1, GIP, and glucagon. This sets it apart from Lilly’s existing injectable obesity drug Zepbound, which targets GLP-1 and GIP, and rival Novo Nordisk’s Wegovy, which targets only GLP-1.
An 80-week trial involving adults with severe obesity and established heart disease showed average weight loss of 22.6 percent at the highest weekly dose of retatrutide.
Analysts said the results reinforced the drug’s strong weight loss potential within Lilly’s expanding cardiometabolic portfolio, even as high expectations limited any major stock movement.
Major cardiovascular events occurred less often than expected across both the treatment and placebo groups. When looking specifically at the three most severe events, heart attack, stroke, and death, patients on retatrutide showed a 12 percent higher risk than those on placebo.
Analysts noted the limited dataset made the imbalance difficult to interpret, while pointing to encouraging directional benefits among patients who stayed on treatment.
A separate 80-week trial of overweight or obese patients with type 2 diabetes found that those on the highest dose lost 20.8 percent of their body weight and lowered A1C levels by 1.6 percent. Nausea and diarrhea remained the most common side effects across both trials.
Lilly had earlier reported that obesity patients without diabetes lost an average of 28.3 percent of their weight in a similar trial, alongside positive Phase 3 results for knee osteoarthritis pain and obstructive sleep apnea.
Lilly Executive Vice President Kenneth Custer said the five positive Phase 3 studies point to retatrutide’s strong efficacy and its potential role in cardiometabolic health management.
