FDA clears IND and first patient dosed in Alveus’ phase 1b trial of ALV-100 for obesity

The FDA has cleared Alveus Therapeutics’ Investigational New Drug (IND) application for ALV-100, the company’s lead investigational therapy for chronic weight management, enabling initiation of a Phase 1b clinical study. The first patient was dosed last week.

ALV-100 is a bifunctional glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist / glucagon-like peptide-1 receptor (GLP-1R) agonist fusion protein designed to address long-term weight management and tolerability in adults with obesity. The Phase 1b study is a randomised, double-blind, placebo-controlled, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered ALV-100 in adults with overweight or obesity, with or without type 2 diabetes. Approximately 180 patients will be enrolled across multiple US clinical sites.

“Following the successful close of our Series A financing earlier this month, we moved quickly to advance ALV-100 into the clinic in the United States,” said Raj Kannan, Chief Executive Officer of Alveus. “ALV-100 was designed not only to drive robust weight loss but also to support long-term weight maintenance with a simpler treatment approach. This IND clearance and first patient dosing are critical steps toward building a robust Phase 3 program.”

ALV-100 is being developed to support long-term weight management with a focus on convenience and tolerability. Alveus’ strategy is focused on evaluating dosing regimens that better match real-world patient needs over time.

“We believe combining GIPR antagonism with GLP-1 receptor agonism can support long-term weight management with a better treatment experience,” said Dr Jacob Jeppesen, Chief Scientific Officer and Head of R&D at Alveus. “This Phase 1b study is the first of several planned milestones as we move toward Phase 3 readiness in the second half of 2027.”