PFE - Lilly obesity therapy shows ~16% weight loss in Phase 3 trial

2023-04-27 06:55:09 ET

Eli Lilly ( NYSE: LLY ) announced Thursday that its experimental weight loss therapy, tirzepatide, generated up to 15.7% of weight loss, and the company expects the FDA to decide on its approval as early as late 2023.

Tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, is already available in the U.S. under the brand name Mounjaro as a treatment for adults with type 2 diabetes mellitus.

Citing data from its SURMOUNT-2 global phase 3 clinical trial, LLY said that the study met the co-primary objectives as participants witnessed average weight reductions of 13.4% and 15.7% on 10 mg and 15 mg of tirzepatide, respectively, compared to placebo at 72 weeks.

SURMOUNT-2 also met the other co-primary endpoint as 81.6% and 86.4% of people under the study drug at 10 mg and 15 mg achieved at least 5% body weight reduction, respectively, compared to 30.5% in the placebo group.

Tirzepatide also achieved all key secondary objectives of the trial, including cardiometabolic parameters such as A1C reduction.

The safety profile was in line with findings from previously completed SURMOUNT and SURPASS trials, and gastrointestinal-related side effects such as nausea and diarrhea with mild-to-moderate severity were among the most commonly reported adverse events.

However, ~4% and ~7% of patients who received 10 mg and 15 mg dose levels discontinued the study due to adverse events, respectively, compared to ~4% in the placebo group.

The results are yet to undergo peer review, and LLY plans to present the data at an upcoming medical event.

Expecting a regulatory action later this year, the company also intends to complete its rolling submission for tirzepatide to the FDA in the coming weeks targeting adults with obesity or overweight with weight-related issues.

Novo Nordisk ( NVO ), which already markets the FDA-cleared weight loss therapy Wegovy and Lilly ( LLY ), are front runners in the global obesity market, expected to reach $54B by 2030, according to Morgan Stanley.

In addition to Novo ( NVO ) and Lilly ( LLY ), drugmakers such as Amgen ( AMGN ), Pfizer ( PFE ), Altimmune ( ALT ), vTv Therapeutics ( VTVT ), Rhythm Pharmaceuticals ( RYTM ), Viking Therapeutics ( VKTX ) are also advancing weight loss candidates.

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