STRIDES

TerminatedPhase 2

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Proof-of-Concept Study to Investigate Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over (STRIDES)

Lead sponsor

BioAge Labs, Inc.

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

204

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-40

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06515418

Org study IDBGE-105-005

Timeline

Milestones

Study start2024-06-27actual

Study first posted2024-07-23actual

Primary completion2025-02-06actual

Study completion2025-02-12actual

Last update posted2025-03-13actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Male or female, 55 years of age or older at the time of signing the informed consent.

2. Have a BMI between 30 and 40 kg/m2 inclusive at the time of screening.

3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

1. Have diagnosis of type 1 diabetes (T1D) or Type 2 diabetes (T2D) mellitus.

2. Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening.

3. Have a prior or planned surgical treatment or device-based therapy for obesity.

4. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).

5. Have an uncontrolled thyroid disease.

6. Have obesity induced by endocrinological disorders.

7. Have biopsy-confirmed nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH).

8. Have a known history or presence of severe active acute or chronic livers disease or acute or chronic pancreatitis, or exocrine pancreatic insufficiency.

9. Have a known history or presence of symptomatic gallbladder disease within the past 2 years.

10. Have a medically significant cardiovascular condition.

11. Have a history of active or untreated malignancy within the last 5 years.

12. Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.

13. Have any lifetime history of a suicide attempt.

14. Have a known clinically significant gastric emptying abnormality.

15. Have had previous or are currently on treatment with a GLP-1R agonist or tirzepatide (a dual agonist of GLP-1 and GIP receptors).

16. Are currently using warfarin.

17. Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening.

18. Have current or history of treatment with medications that may cause significant weight gain within 90 days of screening.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Weight & body composition

8 endpoints

Primary/protocol endpoint

Mean Percent Change in Body Weight (Azelaprag Once per Day)

Time frame:Week 24

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Mean Percent Change in Body Weight (Azelaprag Twice per Day)

Time frame:Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

≥5% Body Weight Reduction

Time frame:Week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

≥10% Body Weight Reduction

Time frame:Week 24

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

≥15% Body Weight Reduction

Time frame:Week 24

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

≥20% Body Weight Reduction

Time frame:Week 24

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body Weight Change

Time frame:Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist Circumference Change

Time frame:Week 24

Waist circumference, change

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Serious Adverse Events

Time frame:Up to Week 36

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Treatment Emergent Adverse Events

Time frame:Up to Week 36

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.