MBX 4291 / MBX Biosci - LARVOL DELTA

Obesity: MBX 4291 (GlobeNewswire) - "Planned 12-week MAD portion: Following completion of Parts A and B, the Company plans to evaluate multiple ascending doses of MBX 4291, or matching placebo, administered over 12 weeks in up to two cohorts consisting of 30 participants each in a 2:1 randomization ratio. Participants are expected to receive up to a total of 12 study intervention administrations one week or one week and one month apart with increasing doses of MBX 4291 and will be followed for 120 days after the first dose. Results from the planned 12-week MAD portion are expected in Q4 2026."

P1 data • Trial status • Obesity

MBX Biosciences Doses First Participant in Phase 1 Trial of MBX 4291 for the Treatment of Obesity (GlobeNewswire) - "The Phase 1 trial is a randomized, double-blind, placebo-controlled first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 4291 in adult participants with obesity."

Trial status • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: MBX Biosciences

New P1 trial • Genetic Disorders • Obesity

MBX Biosciences Announces IND Submission of MBX 4291, its Long-acting GLP1/GIP Receptor Co-agonist Prodrug for the Treatment of Obesity (GlobeNewswire) - "MBX Biosciences...announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MBX 4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity....'Following IND clearance, we plan to initiate a Phase 1 trial evaluating MBX 4291 in healthy overweight volunteers in the third quarter of 2025'."

IND • New P1 trial • Obesity

MBX Biosciences Reports First Quarter 2025 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "IND application submission on track for Q2 2025: MBX 4291, a GLP-1/GIP co-agonist prodrug, is being developed as a once-monthly treatment for obesity. The Company expects to submit an IND application for MBX 4291 this quarter."

IND • Obesity

MBX 4291: IND filing on track for Q2 2025 (GlobeNewswire) - "MBX expects to submit an IND application to the FDA in the second quarter of 2025 for MBX 4291, the Company’s GLP-1/GIP co-agonist prodrug for the potential once-monthly treatment of obesity."

IND • Obesity