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Azelaprag + Tirzepatide for Obesity (STRIDES 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

Must not have

Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Uncontrolled thyroid disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 36

Awards & highlights

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

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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of MTC or MEN-2 in my family or myself.

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My thyroid condition is not under control.

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I have been diagnosed with NASH or MASH through a biopsy.

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I do not have severe liver disease or pancreatitis.

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I have a serious heart condition.

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My obesity is caused by a hormone disorder.

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I am currently taking warfarin.

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I haven't used any weight loss drugs or supplements in the last 90 days.

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I have been diagnosed with type 1 or type 2 diabetes.

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I have had or am planning to have surgery or use a device to help with weight loss.

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I have been treated with GLP-1R agonist or tirzepatide.

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I have not had any active or untreated cancer in the last 5 years.

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I have not had a severe mental health issue in the past 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 36

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

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,640 Previous Clinical Trials

3,221,424 Total Patients Enrolled

60 Trials studying Obesity

52,367 Patients Enrolled for Obesity

BioAge Labs, Inc.Lead Sponsor

4 Previous Clinical Trials

210 Total Patients Enrolled

~147 spots leftby Sep 2025

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