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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
204
Site 110
Mesa, Arizona, United States
Site 107
Los Angeles, California, United States
Site 103
Montclair, California, United States
Site 105
Spring Valley, California, United States
Site 100
Louisville, Kentucky, United States
Site 101
Marrero, Louisiana, United States
Site 112
Boston, Massachusetts, United States
Site 111
Troy, Michigan, United States
Site 113
City of Saint Peters, Missouri, United States
Site 106
Butte, Montana, United States
...and 4 more locations
Mean Percent Change in Body Weight (Azelaprag Once per Day)
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
Time frame: Week 24
Mean Percent Change in Body Weight (Azelaprag Twice per Day)
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
Time frame: Week 24
≥5% Body Weight Reduction
Proportion of study participants at 24 weeks who achieve ≥5% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone
Time frame: Week 24
≥10% Body Weight Reduction
Proportion of study participants at 24 weeks who achieve ≥10% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone
Time frame: Week 24
≥15% Body Weight Reduction
Proportion of study participants at 24 weeks who achieve ≥15% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone
Time frame: Week 24
≥20% Body Weight Reduction
Proportion of study participants at 24 weeks who achieve ≥20% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone
Time frame: Week 24
Body Weight Change
Change from baseline in body weight (kg) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone
Time frame: Week 24
Waist Circumference Change
Change from baseline in in waist circumference (cm) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone
Time frame: Week 24
Serious Adverse Events
The incidence of serious adverse events (SAEs)
Time frame: Up to Week 36
Treatment Emergent Adverse Events
The incidence of treatment emergent adverse events
Time frame: Up to Week 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.