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

March 11, 2025 updated by: BioAge Labs, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Site 110
    • California
      • Los Angeles, California, United States, 90057
        • Site 107
      • Montclair, California, United States, 91763
        • Site 103
      • Spring Valley, California, United States, 91978
        • Site 105
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Site 100
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Site 101
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Site 112
    • Michigan
      • Troy, Michigan, United States, 48098
        • Site 111
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • Site 113
    • Montana
      • Butte, Montana, United States, 59701
        • Site 106
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Site 109
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Site 108
    • Texas
      • Dallas, Texas, United States, 75230
        • Site 102
    • Utah
      • Saint George, Utah, United States, 84790
        • Site 104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A: Tirzepatide Monotherapy
  • Azelaprag placebo every morning
  • Azelaprag placebo every evening
  • Tirzepatide 5mg once weekly
Drug: Oral Placebo for Azelaprag (BGE-105)
Capsules
Other Names:
  • Placebo
Drug: Tirzepatide
Subcutaneous Injection
Experimental: B: Azelaprag once daily plus Tirzepatide
  • Azelaprag 300mg every morning
  • Azelaprag placebo every evening
  • Tirzepatide 5mg once weekly
Drug: Oral Placebo for Azelaprag (BGE-105)
Capsules
Other Names:
  • Placebo
Drug: Tirzepatide
Subcutaneous Injection
Drug: Oral Azelaprag (BGE-105)
Capsules
Other Names:
  • BGE-105
Experimental: C: Azelaprag twice daily plus Tirzepatide
  • Azelaprag 300mg every morning
  • Azelaprag 300mg every evening
  • Tirzepatide 5mg once weekly
Drug: Tirzepatide
Subcutaneous Injection
Drug: Oral Azelaprag (BGE-105)
Capsules
Other Names:
  • BGE-105
Experimental: D: Azelaprag Monotherapy
  • Azelaprag 300mg every morning
  • Azelaprag 300mg every evening
  • Tirzepatide placebo once weekly
Drug: Oral Azelaprag (BGE-105)
Capsules
Other Names:
  • BGE-105
Drug: Tirzepatide Placebo
Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change in Body Weight (Azelaprag Once per Day)
Time Frame: Week 24
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)
Time Frame: Week 24
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
≥5% Body Weight Reduction
Time Frame: Week 24
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
Time Frame: Week 24
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
Time Frame: Week 24
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
Time Frame: Week 24
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
Time Frame: Week 24
Change from baseline in body weight (kg) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone
Week 24
Waist Circumference Change
Time Frame: Week 24
Change from baseline in in waist circumference (cm) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone
Week 24
Serious Adverse Events
Time Frame: Up to Week 36
The incidence of serious adverse events (SAEs)
Up to Week 36
Treatment Emergent Adverse Events
Time Frame: Up to Week 36
The incidence of treatment emergent adverse events
Up to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioAge Labs, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGE-105-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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