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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
BioAge Labs, Inc.
Study ID
NCT06515418
Phase
PHASE2
Status
Terminated

Conditions

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

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)

FacilityCityStateZIPSite coordinators
Site 110MesaArizona85210-
Site 107Los AngelesCalifornia90057-
Site 103MontclairCalifornia91763-
Site 105Spring ValleyCalifornia91978-
Site 100LouisvilleKentucky40213-
Site 101MarreroLouisiana70072-
Site 112BostonMassachusetts02114-
Site 111TroyMichigan48098-
Site 113City of Saint PetersMissouri63303-
Site 106ButteMontana59701-
Site 109FargoNorth Dakota58104-
Site 108BeachwoodOhio44122-
Site 102DallasTexas75230-
Site 104St. GeorgeUtah84790-

Find similar trials in Mesa, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Site 110· Mesa, AZSite 107· Los Angeles, CASite 103· Montclair, CASite 105· Spring Valley, CASite 100· Louisville, KYSite 101· Marrero, LA

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