TLDR
- Eli Lilly will file for FDA approval of retatrutide in Q1 2027, delayed from its original 2025 target
- In Phase 3 trials, patients with obesity and Type 2 diabetes lost an average of 20.8% body weight (nearly 50 lbs) at 80 weeks
- Patients with obesity and cardiovascular disease lost an average of 22.6% body weight (~55.8 lbs) at 80 weeks
- Retatrutide targets three hormones (GLP-1, GIP, glucagon), compared to one or two for rival drugs
- Analysts at TD Cowen estimate retatrutide could hit $3.8 billion in sales by 2030
Eli Lilly announced Thursday it plans to file for regulatory approval of retatrutide, its next-generation obesity drug, in the first quarter of 2027. The timeline is a delay from an earlier target of 2025. LLY stock was up 1.99% on the day.
The company said it needs more time to collect and verify manufacturing and quality-control data required by regulators.
Retatrutide is a weekly injection. It passed two additional Phase 3 clinical trials, posting weight loss results that outpace current treatments on the market.
In one trial, adults with obesity and Type 2 diabetes lost an average of 20.8% of their body weight — nearly 50 pounds — over 80 weeks.
In a second trial, adults with severe obesity and established cardiovascular disease lost an average of 22.6% of their body weight, or about 55.8 pounds, over the same period.
How Retatrutide Differs From Existing Drugs
What sets retatrutide apart is how it works. The drug targets three hormones: GLP-1, GIP, and glucagon.
Lilly’s current blockbuster, Zepbound, targets GLP-1 and GIP. Novo Nordisk’s Wegovy hits only GLP-1. Retatrutide’s triple-hormone approach is new ground in the obesity drug space.
Side effects reported in the trials included diarrhea, nausea, and constipation — consistent with others in the GLP-1 drug class.
Kenneth Custer, president of Lilly Cardiometabolic Health, said the company believes it has what it needs to file globally, targeting not just obesity but also knee osteoarthritis pain and obstructive sleep apnea.
Analyst Outlook and Wall Street View
TD Cowen analysts estimated in January that retatrutide could generate $3.8 billion in sales by 2030. That would make it a major pillar of Lilly’s obesity portfolio alongside Zepbound and its newly launched pill, Foundayo.
Lilly’s push with retatrutide is also a direct play to hold its lead over Novo Nordisk in the global weight-loss drug market.
Among 22 Wall Street analysts covering LLY, the consensus is a Strong Buy. That rating is based on 20 Buy and two Hold recommendations issued over the past three months.
The average LLY price target sits at $1,294.06, implying roughly 17% upside from current levels.
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