Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over

NCT06515418 · Terminated

Last updated 2026-05-28

This clinical trial is testing whether adding an experimental oral medication called azelaprag to an existing weight-loss drug called tirzepatide works better than tirzepatide alone in adults aged 55 and older who have obesity.

Status Terminated Stopped early and will not restart.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 204 people

Who can join Ages 55+ · all sexes

Timeline Started 2024-06 · est. completion 2025-02

Where 14 sites · United States

What this study is testing ClinicalTrials.gov NCT06515418 ↗

Description as written by the study sponsor.

This study aims to find out how well a combination of oral azelaprag taken once a day (QD) or twice a day (BID), along with a weekly injection of tirzepatide, works for weight management in adults 55 years and older. The researchers are also looking at safety. Estimated Study Length: * with the optional prescreening, the study duration may be up to 48 weeks. * the treatment duration will be 24 weeks followed by 12 weeks follow-up. * the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter.

Treatments tested

Oral Azelaprag (BGE-105) also known as BGE-105 Drug

Capsules
Oral Placebo for Azelaprag (BGE-105) also known as Placebo Drug

Capsules
Tirzepatide Drug

Subcutaneous Injection
Tirzepatide Placebo Drug

Subcutaneous Injection

Main thing measured	Mean Percent Change in Body Weight (Azelaprag Once per Day)
Sponsor	BioAge Labs, Inc.
Conditions studied	Obesity
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06515418 ↗