Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared With Tirzepatide Alone in Participants With Obesity Aged 55 Years and Over
NCT Number: NCT06515418
Acronym: STRIDES
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity
Interventions: DRUG: Oral Azelaprag (BGE-105)|DRUG: Oral Placebo for Azelaprag (BGE-105)|DRUG: Tirzepatide|DRUG: Tirzepatide Placebo
Sponsor: BioAge Labs, Inc.
Collaborators: Eli Lilly and Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2025-12
Locations: Site 110, Mesa, Arizona, 85210, United States|Site 107, Los Angeles, California, 90057, United States|Site 103, Montclair, California, 91763, United States|Site 105, Spring Valley, California, 91978, United States|Site 114, Macon, Georgia, 31210, United States|Site 100, Louisville, Kentucky, 40213, United States|Site 101, Marrero, Louisiana, 70072, United States|Site 112, Boston, Massachusetts, 02114, United States|Site 111, Troy, Michigan, 48098, United States|Site 113, Saint Peters, Missouri, 63303, United States|Site 106, Butte, Montana, 59701, United States|Site 109, Fargo, North Dakota, 58104, United States|Site 108, Beachwood, Ohio, 44122, United States|Site 102, Dallas, Texas, 75230, United States|Site 104, Saint George, Utah, 84790, United States

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.

Primary Outcome Measures: 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, 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, Week 24
Secondary Outcome Measures: ≥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, 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, 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, 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, Week 24|Body Weight Change, Change from baseline in body weight (kg) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone, Week 24|Waist Circumference Change, Change from baseline in in waist circumference (cm) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone, Week 24|Serious Adverse Events, The incidence of serious adverse events (SAEs), Up to Week 36|Treatment Emergent Adverse Events, The incidence of treatment emergent adverse events, Up to Week 36