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

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oral Azelaprag (BGE-105) — DRUG
  Capsules
• Oral Placebo for Azelaprag (BGE-105) — DRUG
  Capsules
• Tirzepatide — DRUG
  Subcutaneous Injection
• Tirzepatide Placebo — DRUG
  Subcutaneous Injection

Study Details

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.

Key Dates

First listed

Jul 23, 2024

Start date

Jun 27, 2024

Status verified

Mar 2025

Primary completion

Feb 6, 2025

Completion

Feb 12, 2025

Study Design

Enrollment

204 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: A: Tirzepatide Monotherapy
  * Azelaprag placebo every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
• Experimental: B: Azelaprag once daily plus Tirzepatide
  * Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
• Experimental: C: Azelaprag twice daily plus Tirzepatide
  * Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide 5mg once weekly
• Experimental: D: Azelaprag Monotherapy
  * Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide placebo once weekly

Primary Outcome Measure

Mean Percent Change in Body Weight (Azelaprag Once per Day) [ Time Frame: Week 24 ]

Locations (14)

Find similar trials in Mesa, AZ

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