Eli Lilly Moves Closer To Another Weight-Loss Drug: Retatrutide Clears Two More Phase 3 Trials Ahead Of FDA Filing

• Lilly said it plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the first quarter of 2027.
• In Triumph-2, patients receiving the highest 12 mg dose lost around 20.8% of their body weight over 80 weeks.
• In the Triumph-3 trial, participants lost up to 22.6% of their body weight over the same period.

Eli Lilly (LLY) was in the limelight in pre-market trading on Thursday, after the pharmaceutical giant reported positive topline results from two late-stage clinical trials of its investigational obesity drug Retatrutide, strengthening its position in the rapidly growing weight-loss market as competition with Novo Nordisk (NVO) intensifies.

Lilly said it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027.

LLY stock has been under some pressure lately, tracking its third consecutive weekly decline. It was down 0.5% in Thursday’s premarket session at the time of writing.

Significant Weight Loss Seen Across Two Studies

Retatrutide, a once-weekly triple hormone receptor agonist targeting GIP, GLP-1, and glucagon receptors, met the primary endpoint in both the Triumph-2 and Triumph-3 Phase 3 studies.

In Triumph-2, which enrolled 1,152 participants, patients receiving the highest 12 mg dose lost an average of 49.6 pounds, or 20.8% of their body weight, over 80 weeks. The treatment also reduced A1C (blood sugar) levels by up to 1.6%.

In Triumph-3, adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes, lost up to 55.8 pounds, or 22.6% of their body weight, over the same period.

Data Supports Global Submissions For Retatrutide

The study also showed improvements in several cardiovascular risk factors, including lower triglycerides, non-HDL cholesterol, systolic blood pressure, waist circumference, and inflammation markers.

Lilly said it is completing the manufacturing data required for its regulatory submission, with a U.S. filing expected in early 2027.

“With the positive results from Triumph-2 and Triumph-3, we now have the clinical data package to support global submissions for Retatrutide as a potential treatment for obesity, knee osteoarthritis pain, and obstructive sleep apnea. We look forward to working with regulators as they evaluate this first-of-its-kind medicine,” said Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health.

GLP-1 Competition Intensifies

The latest results come as competition in the obesity drug market continues to intensify. Earlier this week, Novo Nordisk sued Lilly, alleging the company ran misleading advertising campaigns for its blockbuster diabetes and weight-loss drugs, Zepbound and Mounjaro. 

The legal dispute underscores the high stakes in a market that Bloomberg Intelligence estimates could reach $120 billion annually by 2030.

Retail’s Take On LLY

Retail sentiment for LLY on Stocktwits turned ‘bearish’ from ‘neutral’ a day earlier.

LLY shares have gained around 7% so far this year, outperforming NVO’s 8% decline and the broader Roundhill GLP-1 and Weight Loss ETF (OZEM), which is down 6.3%.

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