Altimmune, FDA agree on efficacy measures for phase 3 trial of pemvidutide
seekingalpha
2024-11-08
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Altimmune (NASDAQ:ALT) and the U.S. FDA have reached agreement on the efficacy and safety measures to be evaluated in the company's phase 3 trials of obesity asset pemvidutide following an end-of-phase 2 meeting.
The phase 3 program will encompass four randomized, double-blind, placebo-controlled trials lasting 60 weeks and enroll a total of 5,000 participants. Three dosage strength will be tested -- 1.2 mg, 1.8 mg, and 2.4 mg -- and the company said it is aiming for approval of all strengths.
Each trial will enroll subjects with different comorbidities. For example, one will enroll individuals who are obese or overweight without diabetes, another in those with high LDL cholesterol, a third in those with elevated liver fat, and a fourth in an elderly population.
Pemvidutide is considered a novel peptide-based GLP-1/glucagon dual receptor agonist.