BioAge Labs has announced plans to launch a Phase II clinical trial of BGE-105 (azelaprag) administered along with tirzepatide to treat individuals with obesity.

Total weight loss will be the trial’s primary endpoint while secondary endpoints will explore the potential benefits of the treatment. 

The company will also obtain aging-linked biomarkers from the trial subjects.

BioAge anticipates commencing this trial mid-next year.

An oral apelin receptor agonist, BGE-105 imitates apelin’s activity, an exerkine peptide released during exercise.

Under an agreement entered by Chorus and BioAge, the former will provide guidance and assistance on all steps of the Phase II trial design and execution.

A clinical development organisation within Eli Lilly and Company, Chorus aids biotechs in developing their assets from the candidate stage to clinical proof of concept.

Furthermore, Lilly will offer tirzepatide for BioAge’s trial.

BioAge CEO and co-founder Kristen Fortney said: “We are thrilled to work directly with the clinical development experts at Chorus and benefit from Lilly’s expertise in obesity drug development. 

“Our Phase II trial is designed to assess whether azelaprag can substantially increase the weight loss achieved with drugs of the incretin class. 

“The oral route of administration of azelaprag makes it particularly exciting as a combination partner for next-generation oral incretins currently in development.”

The company reported positive topline data from a Phase Ib clinical trial of azelaprag in December last year.  

Findings showed that the treatment prevented muscle atrophy and preserved muscle protein synthesis in healthy subjects aged 65 years or above following ten days of bed rest.

Azelaprag was also well tolerated in the trial and at all the evaluated doses with safety profile in line with the prior data.

Preclinical research showed that the combination of azelaprag plus tirzepatide offered elevated total weight loss compared to tirzepatide alone in diet-induced obese mice.