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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Terminated PHASE2 INTERVENTIONAL NCT06515418

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Detailed Description

Clinical trial BGE-105-005 will determine if the addition of oral azelaprag to tirzepatide treatment will amplify overall weight loss in participants with obesity aged 55 years and older. BGE-105-005 is a randomized, double-blind, placebo-controlled, parallel-arm, multi-center study in approximately 220 adults ≥55 years old with body mass index (BMI) between 30 and 40 kg/m2 inclusive, at the time of screening. Participants will be randomly assigned to 1 of the 4 study arms (A-tirzepatide monotherapy, B-azelaprag 300 mg QD plus tirzepatide, C-azelaprag 300 mg BID plus tirzepatide, D-azelaprag 300 mg BID monotherapy). The primary endpoint will be the effect on body weight reduction as measured by mean percent change in body weight at 24 weeks in participants that received azelaprag plus tirzepatide versus tirzepatide alone. The study is intended to gather safety and efficacy data in the defined participant population.

Interventions

Name: Oral Azelaprag (BGE-105)
Type: DRUG
Description: Capsules
Name: Oral Placebo for Azelaprag (BGE-105)
Type: DRUG
Description: Capsules
Name: Tirzepatide
Type: DRUG
Description: Subcutaneous Injection
Name: Tirzepatide Placebo
Type: DRUG
Description: Subcutaneous Injection

Primary Outcomes

Measure: Mean Percent Change in Body Weight (Azelaprag Once per Day)
TimeFrame: Week 24
Description: Mean percent change in body weight from baseline to Week 24 in the 300 mg azelaprag once per day (QD) plus tirzepatide arm compared to tirzepatide alone arm
Measure: Mean Percent Change in Body Weight (Azelaprag Twice per Day)
TimeFrame: Week 24
Description: Mean percent change in body weight from baseline to Week 24 in the 300 mg azelaprag twice per day (BID) plus tirzepatide arm compared to tirzepatide alone arm

Trial Information

NCT ID

NCT06515418

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

BioAge Labs, Inc.

Last Updated

December 15, 2025