ObesityPhase 2STRIDESNCT06515418
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 study testing Oral Azelaprag (BGE-105) and Tirzepatide in people with Obesity, run by BioAge Labs, Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Oral Azelaprag (BGE-105) and Tirzepatide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 Jun 2024to 12 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 55 years of age or older at the time of signing the informed consent.
- Have a BMI between 30 and 40 kg/m2 inclusive at the time of screening.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Who cannot join
- Have diagnosis of type 1 diabetes (T1D) or Type 2 diabetes (T2D) mellitus.
- Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening.
- Have a prior or planned surgical treatment or device-based therapy for obesity.
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- Have an uncontrolled thyroid disease.
- Have obesity induced by endocrinological disorders.
Show all 18Show fewer
- Have biopsy-confirmed nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH).
- Have a known history or presence of severe active acute or chronic livers disease or acute or chronic pancreatitis, or exocrine pancreatic insufficiency.
- Have a known history or presence of symptomatic gallbladder disease within the past 2 years.
- Have a medically significant cardiovascular condition.
- Have a history of active or untreated malignancy within the last 5 years.
- Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
- Have any lifetime history of a suicide attempt.
- Have a known clinically significant gastric emptying abnormality.
- Have had previous or are currently on treatment with a GLP-1R agonist or tirzepatide (a dual agonist of GLP-1 and GIP receptors).
- Are currently using warfarin.
- Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening.
- Have current or history of treatment with medications that may cause significant weight gain within 90 days of screening.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Site 108
Beachwood, Ohio, 44122
Site 112
Boston, Massachusetts, 02114
Site 106
Butte, Montana, 59701
Site 113
City of Saint Peters, Missouri, 63303
Site 102
Dallas, Texas, 75230
Site 109
Fargo, North Dakota, 58104
Site 107
Los Angeles, California, 90057
Site 100
Louisville, Kentucky, 40213
Site 101
Marrero, Louisiana, 70072
Site 110
Mesa, Arizona, 85210
Site 103
Montclair, California, 91763
Site 105
Spring Valley, California, 91978
Site 104
St. George, Utah, 84790
Site 111
Troy, Michigan, 48098
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Oral Azelaprag (BGE-105), Oral Placebo for Azelaprag (BGE-105), Tirzepatide, Tirzepatide Placebo
- Keywords
- Azelaprag, BGE-105, BioAge, Tirzepatide, Weight Management, GLP-1/GIP Receptor Agonist, STRIDES
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Azelaprag (BGE-105)Drug
Also called BGE-105
Capsules
Oral Placebo for Azelaprag (BGE-105)Drug
Also called Placebo
Capsules
TirzepatideDrug
Subcutaneous Injection
Tirzepatide PlaceboDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| A: Tirzepatide Monotherapy | Active comparator | * Azelaprag placebo every morning
* Azelaprag placebo every evening
* Tirzepatide 5mg once weekly Receives: Drug: Oral Placebo for Azelaprag (BGE-105); Drug: Tirzepatide |
| B: Azelaprag once daily plus Tirzepatide | Experimental | * Azelaprag 300mg every morning
* Azelaprag placebo every evening
* Tirzepatide 5mg once weekly Receives: Drug: Oral Azelaprag (BGE-105); Drug: Oral Placebo for Azelaprag (BGE-105); Drug: Tirzepatide |
| C: Azelaprag twice daily plus Tirzepatide | Experimental | * Azelaprag 300mg every morning
* Azelaprag 300mg every evening
* Tirzepatide 5mg once weekly Receives: Drug: Oral Azelaprag (BGE-105); Drug: Tirzepatide |
| D: Azelaprag Monotherapy | Experimental | * Azelaprag 300mg every morning
* Azelaprag 300mg every evening
* Tirzepatide placebo once weekly Receives: Drug: Oral Azelaprag (BGE-105); Drug: Tirzepatide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 24
Secondary outcomes (8)
≥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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 24
Body Weight Change
Change from baseline in body weight (kg) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone
Measured: Week 24
Waist Circumference Change
Change from baseline in in waist circumference (cm) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone
Measured: Week 24
Serious Adverse Events
The incidence of serious adverse events (SAEs)
Measured: Up to Week 36
Treatment Emergent Adverse Events
The incidence of treatment emergent adverse events
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start27 Jun 2024
- Primary completion6 Feb 2025
- Study completion12 Feb 2025
Why it stopped: Dosing of both study drugs has been discontinued due to observation of liver transaminitis without clinically significant symptoms in some subjects receiving azelaprag. All participant visits have been completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAge Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515418
- Sponsor's protocol ID
- BGE-105-005
- Acronym
- STRIDES
- Status last verified
- Mar 2025
- First submitted
- 17 Jul 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06515418
- Acronym / sponsor ID
- STRIDES / BGE-105-005
- Conditions
- Obesity
- Keywords
- Azelaprag, BGE-105, BioAge, Tirzepatide, Weight Management, GLP-1/GIP Receptor Agonist, STRIDES
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dosing of both study drugs has been discontinued due to observation of liver transaminitis without clinically significant symptoms in some subjects receiving azelaprag. All participant visits have been completed.
- Enrolment
- 204 participants (actual)
- Lead sponsor
- BioAge Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Tirzepatide Monotherapy | Active comparator | Drug: Oral Placebo for Azelaprag (BGE-105), Drug: Tirzepatide* Azelaprag placebo every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly |
| B: Azelaprag once daily plus Tirzepatide | Experimental | Drug: Oral Azelaprag (BGE-105), Drug: Oral Placebo for Azelaprag (BGE-105), Drug: Tirzepatide* Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly |
| C: Azelaprag twice daily plus Tirzepatide | Experimental | Drug: Oral Azelaprag (BGE-105), Drug: Tirzepatide* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide 5mg once weekly |
| D: Azelaprag Monotherapy | Experimental | Drug: Oral Azelaprag (BGE-105), Drug: Tirzepatide Placebo* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide placebo once weekly |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 55 years of age or older at the time of signing the informed consent.
- Have a BMI between 30 and 40 kg/m2 inclusive at the time of screening.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Key exclusion criteria (18 listed)
- Have diagnosis of type 1 diabetes (T1D) or Type 2 diabetes (T2D) mellitus.
- Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening.
- Have a prior or planned surgical treatment or device-based therapy for obesity.
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- Have an uncontrolled thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Azelaprag (BGE-105)Also: BGE-105Capsules | Drug | B: Azelaprag once daily plus Tirzepatide, C: Azelaprag twice daily plus Tirzepatide, D: Azelaprag Monotherapy |
| Oral Placebo for Azelaprag (BGE-105)Also: PlaceboCapsules | Drug | A: Tirzepatide Monotherapy, B: Azelaprag once daily plus Tirzepatide |
| TirzepatideSubcutaneous Injection | Drug | A: Tirzepatide Monotherapy, B: Azelaprag once daily plus Tirzepatide, C: Azelaprag twice daily plus Tirzepatide |
| Tirzepatide PlaceboSubcutaneous Injection | Drug | D: Azelaprag Monotherapy |
Primary outcome
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
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
8 secondary outcomes
≥5% Body Weight Reduction
Time frame: Week 24
≥10% Body Weight Reduction
Time frame: Week 24
≥15% Body Weight Reduction
Time frame: Week 24
≥20% Body Weight Reduction
Time frame: Week 24
Body Weight Change
Time frame: Week 24
Waist Circumference Change
Time frame: Week 24
Serious Adverse Events
Time frame: Up to Week 36
Treatment Emergent Adverse Events
Time frame: Up to Week 36
Results and safety
The study was stopped early (reason given: Dosing of both study drugs has been discontinued due to observation of liver transaminitis without clinically significant symptoms in some subjects receiving azelaprag. All participant visits have been completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Zepbound™ USPILink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Azelaprag (BGE-105) and Tirzepatide in people with Obesity, run by BioAge Labs, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Dosing of both study drugs has been discontinued due to observation of liver transaminitis without clinically significant symptoms in some subjects receiving azelaprag. All participant visits have been completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in Body Weight (Azelaprag Once per Day) (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.