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

NCT06515418 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Oral Azelaprag (BGE-105)

Capsules

DRUG

Oral Placebo for Azelaprag (BGE-105)

Capsules

DRUG

Tirzepatide

Subcutaneous Injection

DRUG

Tirzepatide Placebo

Subcutaneous Injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-27
Primary Completion
2025-02-06
Completion
2025-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515418 on ClinicalTrials.gov