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Azelaprag + Tirzepatide for Obesity (STRIDES Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by BioAge Labs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 55 years of age or older at the time of signing the informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 36

Summary

This trial is testing a combination of a daily oral medication and a weekly injection to see how well they help with weight management in adults aged 55 and older. The study will last up to 48

Who is the study for?
This trial is for adults aged 55 and over who are dealing with obesity. Participants must be willing to take oral medication daily or twice a day, receive weekly injections, and commit to the study schedule including follow-ups.
What is being tested?
The effectiveness of combining a new oral drug called Azelaprag (taken once or twice daily) with Tirzepatide (a weekly injection) for weight management in older adults is being tested against using Tirzepatide alone.
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea or diarrhea, possible allergic reactions, changes in appetite, fatigue, and other effects that often come with weight loss medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 55 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Percent Change in Body Weight (Azelaprag Once per Day)
Mean Percent Change in Body Weight (Azelaprag Twice per Day)
Secondary study objectives
Body Weight Change
Serious Adverse Events
Treatment Emergent Adverse Events
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: D: Azelaprag MonotherapyExperimental Treatment2 Interventions
* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide placebo once weekly
Group II: C: Azelaprag twice daily plus TirzepatideExperimental Treatment2 Interventions
* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide 5mg once weekly
Group III: B: Azelaprag once daily plus TirzepatideExperimental Treatment3 Interventions
* Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
Group IV: A: Tirzepatide MonotherapyActive Control2 Interventions
* Azelaprag placebo every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,164 Total Patients Enrolled
69 Trials studying Obesity
46,867 Patients Enrolled for Obesity
BioAge Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
210 Total Patients Enrolled
~110 spots leftby Sep 2025
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