AgingPhase 1/2NCT06727305
MTOR Inhibitors in Older Adults
A Phase 1/2 study testing Sirolimus 0.5 Mg Oral Tablet, Sirolimus 1Mg Oral Tablet and Sirolimus 2 MG Oral Tablet in people with Aging, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Sirolimus 0.5 Mg Oral Tablet, Sirolimus 1Mg Oral Tablet and Sirolimus 2 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to 13 Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling adults
- Patients should be 65 Years and older
- Patients is able to understand and follow trial procedures
Who cannot join
- Creatinine clearance <30 mL/min;
- History of chronic liver disease;
- Uncontrolled Hypertension (i.e., systolic blood pressure >160 mm Hg);
- Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
- Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;
- Planned major surgical procedures;
Show all 10Show fewer
- Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);
- Taking medication that increase or decrease sirolimus blood concentrations;
- Other investigational therapy received within 1 month prior to screening visit;
- History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Rhoda Annoh Gordon, PharmD, MPH, 2146457108, Rhoda.annohgordon@utsouthwestern.edu
About this study
Official title: Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .
Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications
Read the detailed description
Study Objectives To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors and determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up in older adults.
Specific Aims:
Aim 1: To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors (sirolimus and everolimus) in older adults.
Aim 2: To determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up.
Exploratory Aim 3: We will also assess the feasibility of collecting the laboratory biomarkers (ESR, CRP, S6K activity, mitochondrial function, metabolomics) and data regarding the functional biomarkers of aging measured by walking speed, chair stand, standing balance, grip strength
- Conditions
- Aging
- Being tested
- Sirolimus 0.5 Mg Oral Tablet, Sirolimus 1Mg Oral Tablet, Sirolimus 2 MG Oral Tablet, Everolimus 0.5 MG Oral Tablet, Everolimus 1 MG Oral Tablet
- Keywords
- Aging, Geriatic, Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus 0.5 Mg Oral TabletDrug
Sirolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Sirolimus 1Mg Oral TabletDrug
Sirolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Sirolimus 2 MG Oral TabletDrug
Sirolimus 2 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 0.5 MG Oral TabletDrug
Everolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 1 MG Oral TabletDrug
Everolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 2 MG Oral TabletDrug
Everolimus 2 mg oral tablets for daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| sirolimus 0.5 mg Arm | Active comparator | Participant would receive 0.5 mg of sirolimus. Receives: Drug: Sirolimus 0.5 Mg Oral Tablet |
| sirolimus 1 mg Arm | Active comparator | Participant would receive 1 mg of sirolimus. Receives: Drug: Sirolimus 1Mg Oral Tablet |
| sirolimus 2 mg Arm | Active comparator | Participant would receive 2 mg of sirolimus. Receives: Drug: Sirolimus 2 MG Oral Tablet |
| everolimus 0.5 mg Arm | Active comparator | Participant would receive 0.5 mg of Everolimus. Receives: Drug: Everolimus 0.5 MG Oral Tablet |
| everolimus 1 mg Arm | Active comparator | Participant would receive 1 mg of Everolimus. Receives: Drug: Everolimus 1 MG Oral Tablet |
| everolimus 2 mg Arm | Active comparator | Participant would receive 2 mg of Everolimus. Receives: Drug: Everolimus 2 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for Sirolimus
Maximum Sirolimus Concentration at Steady State (Cmax)
Measured: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
Cmax for Everolimus
Maximum Everolimus Concentration at Steady State (Cmax)
Measured: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
Ctrough for Sirolimus
Trough Sirolimus Concentration at Steady State (Ctrough)
Measured: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
Ctrough for Everolimus
Trough Everolimus Concentration at Steady State (Ctrough)
Measured: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
AUC for Sirolimus
Sirolimus Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) at Steady State
Measured: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
AUC for Everolimus
Everolimus Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) at Steady State
Measured: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
CL/F for Sirolimus
Sirolimus Apparent Oral Clearance (CL/F)
Measured: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
CL/F for for Everolimus
Everolimus Apparent Oral Clearance (CL/F)
Measured: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
S6K Activity, in Sirolimus cohorts
Pharmacodynamic parameter, S6K Activity, in Sirolimus cohorts
Measured: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose on Day 1 and Day 14
S6K Activity, in Everolimus cohorts
Pharmacodynamic parameter, S6K Activity, in Everolimus cohorts
Measured: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2.5, 3, 4, 6, and 12-hour post dose on Day 1 and Day 14
Senescence-associated secretory phenotype (SASP) index
Clinical biomarker parameter (SASP) index is a clinical biomarker parameter that measures the level of proteins secreted by senescent cells in the body.
Measured: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
Erythrocyte sedimentation rate (ESR)
Clinical biomarker parameter (ESR) is a blood test that detects and monitors inflammation in the body.
Measured: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
C-reactive protein (CRP)
A measure of Clinical biomarker parameter (CRP), is an inflammatory marker.
Measured: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
6-minute walk test (6MWT)
The 6MWT is simply a record of the distance (in meters) traveled by a given patient at his or her self-selected walking speed over a period of six minutes.
Measured: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
Short physical performance battery (SPPB)
Clinical biomarker parameter (SPPB) assesses lower extremity function in older adults. The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardized procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
Measured: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
Secondary outcomes (6)
Change in SASP response at 3 months follow-up
SASP (senescence-associated secretory phenotype) index score is quantified using blood work comparing results at baseline and at 3 months follow-up. Patients with high SASP scores have a poor survival rate, while patients with low SASP scores have a good survival rate.
Measured: Baseline, 3 months
Change in Laboratory Biomarker response (ESR) from baseline at 3 months follow-up
Feasibility of collecting the laboratory biomarker - Erythrocyte sedimentation rate (ESR) is assessed by change in blood work readings ((millimeters per hour [mm/hour])) at 3 months follow-up.
Measured: Baseline, 3 months
Change in laboratory Biomarker response (CRP) from baseline at 3 months follow-up
Feasibility of collecting the laboratory biomarker- C-Reactive Protein (CRP) is assessed by change in blood work readings (mg/dl) at 3 months follow-up.
Measured: Baseline, 3 months
Change in laboratory Biomarker response (S6K activity) from baseline at 3 months follow-up
Feasibility of collecting the laboratory biomarker- S6 Kinase (S6K) activity is assessed by change in blood work readings (mg/dl) at 3 months follow-up.
Measured: Baseline, 3 months
Change in laboratory Biomarker response (mitochondrial function) from baseline at 3 months follow-up
Feasibility of collecting the laboratory biomarker (mitochondrial function) is assessed by change in blood work readings at 3 months follow-up. The mitochondrial function will be measured through the Bioenergetic Health Index. The Bioenergetic Health Index (BHI) is calculated using the following formula: BHI=(ATP-linked×reserve capacity)/(proton leak×non-mitochondrial) - as described by Chacko et al. The expected range is 0-100.
Measured: Baseline, 3 months
Change in laboratory Biomarker response (metabolomics) from baseline at 3 months follow-up
Feasibility of collecting the laboratory biomarker (metabolomics) is assessed by change in blood work readings at 3 months follow-up. Changes in blood metabolomics are quantified by measuring the concentration levels of individual metabolites within a blood sample using techniques like mass spectrometry (MS) or nuclear magnetic resonance (NMR) spectroscopy, where the relative abundance of each metabolite is compared between different samples, allowing for identification of changes in metabolic pathways based on variations in metabolite levels. The unit of measure is "concentration", usually expressed in micromolar (µM) or millimolar (mM), as it represents the quantity of a specific metabolite per unit volume of the sample.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start11 May 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion13 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who will be randomized in 1:1:1:1:1:1 ratios to receive oral tablet doses of sirolimus and everolimus with concentrations of 0.5mg, 1mg, 2mg each
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Irina Timofte, University of Texas Southwestern Medical Center
- Investigators
- Irina Timofte, MD, MS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727305
- Sponsor's protocol ID
- STU-2024-0798
- Other IDs
- 1U01AG081450-01A1
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2024
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .
- ClinicalTrials.gov ID
- NCT06727305
- Acronym / sponsor ID
- STU-2024-0798
- Conditions
- Aging
- Keywords
- Aging, Geriatic, Disability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 13 Nov 2027 (estimated)
- First posted
- 10 Dec 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.
Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications
Detailed description
Study Objectives To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors and determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up in older adults.
Specific Aims:
Aim 1: To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors (sirolimus and everolimus) in older adults.
Aim 2: To determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up.
Exploratory Aim 3: We will also assess the feasibility of collecting the laboratory biomarkers (ESR, CRP, S6K activity, mitochondrial function, metabolomics) and data regarding the functional biomarkers of aging measured by walking speed, chair stand, standing balance, grip strength
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Patients who will be randomized in 1:1:1:1:1:1 ratios to receive oral tablet doses of sirolimus and everolimus with concentrations of 0.5mg, 1mg, 2mg each
| Arm | Type | Receives |
|---|---|---|
| sirolimus 0.5 mg Arm | Active comparator | Drug: Sirolimus 0.5 Mg Oral TabletParticipant would receive 0.5 mg of sirolimus. |
| sirolimus 1 mg Arm | Active comparator | Drug: Sirolimus 1Mg Oral TabletParticipant would receive 1 mg of sirolimus. |
| sirolimus 2 mg Arm | Active comparator | Drug: Sirolimus 2 MG Oral TabletParticipant would receive 2 mg of sirolimus. |
| everolimus 0.5 mg Arm | Active comparator | Drug: Everolimus 0.5 MG Oral TabletParticipant would receive 0.5 mg of Everolimus. |
| everolimus 1 mg Arm | Active comparator | Drug: Everolimus 1 MG Oral TabletParticipant would receive 1 mg of Everolimus. |
| everolimus 2 mg Arm | Active comparator | Drug: Everolimus 2 MG Oral TabletParticipant would receive 2 mg of Everolimus. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Community-dwelling adults
- Patients should be 65 Years and older
- Patients is able to understand and follow trial procedures
Key exclusion criteria (10 listed)
- Creatinine clearance <30 mL/min;
- History of chronic liver disease;
- Uncontrolled Hypertension (i.e., systolic blood pressure >160 mm Hg);
- Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
- Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;
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 |
|---|---|---|
| Sirolimus 0.5 Mg Oral TabletSirolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml. | Drug | sirolimus 0.5 mg Arm |
| Sirolimus 1Mg Oral TabletSirolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml. | Drug | sirolimus 1 mg Arm |
| Sirolimus 2 MG Oral TabletSirolimus 2 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml. | Drug | sirolimus 2 mg Arm |
| Everolimus 0.5 MG Oral TabletEverolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml. | Drug | everolimus 0.5 mg Arm |
| Everolimus 1 MG Oral TabletEverolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml. | Drug | everolimus 1 mg Arm |
| Everolimus 2 MG Oral TabletEverolimus 2 mg oral tablets for daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml. | Drug | everolimus 2 mg Arm |
Primary outcome
Cmax for Sirolimus
Time frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
Maximum Sirolimus Concentration at Steady State (Cmax)
Cmax for Everolimus
Time frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
Maximum Everolimus Concentration at Steady State (Cmax)
Ctrough for Sirolimus
Time frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
Trough Sirolimus Concentration at Steady State (Ctrough)
Ctrough for Everolimus
Time frame: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
Trough Everolimus Concentration at Steady State (Ctrough)
AUC for Sirolimus
Time frame: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
Sirolimus Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) at Steady State
AUC for Everolimus
Time frame: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
Everolimus Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) at Steady State
CL/F for Sirolimus
Time frame: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
Sirolimus Apparent Oral Clearance (CL/F)
CL/F for for Everolimus
Time frame: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose
Everolimus Apparent Oral Clearance (CL/F)
S6K Activity, in Sirolimus cohorts
Time frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose on Day 1 and Day 14
Pharmacodynamic parameter, S6K Activity, in Sirolimus cohorts
S6K Activity, in Everolimus cohorts
Time frame: Predose (0 hour) on Day 14 and 0.5, 1, 1.5, 2.5, 3, 4, 6, and 12-hour post dose on Day 1 and Day 14
Pharmacodynamic parameter, S6K Activity, in Everolimus cohorts
Senescence-associated secretory phenotype (SASP) index
Time frame: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
Clinical biomarker parameter (SASP) index is a clinical biomarker parameter that measures the level of proteins secreted by senescent cells in the body.
Erythrocyte sedimentation rate (ESR)
Time frame: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
Clinical biomarker parameter (ESR) is a blood test that detects and monitors inflammation in the body.
C-reactive protein (CRP)
Time frame: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
A measure of Clinical biomarker parameter (CRP), is an inflammatory marker.
6-minute walk test (6MWT)
Time frame: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
The 6MWT is simply a record of the distance (in meters) traveled by a given patient at his or her self-selected walking speed over a period of six minutes.
Short physical performance battery (SPPB)
Time frame: Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13
Clinical biomarker parameter (SPPB) assesses lower extremity function in older adults. The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardized procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.
6 secondary outcomes
Change in SASP response at 3 months follow-up
Time frame: Baseline, 3 months
Change in Laboratory Biomarker response (ESR) from baseline at 3 months follow-up
Time frame: Baseline, 3 months
Change in laboratory Biomarker response (CRP) from baseline at 3 months follow-up
Time frame: Baseline, 3 months
Change in laboratory Biomarker response (S6K activity) from baseline at 3 months follow-up
Time frame: Baseline, 3 months
Change in laboratory Biomarker response (mitochondrial function) from baseline at 3 months follow-up
Time frame: Baseline, 3 months
Change in laboratory Biomarker response (metabolomics) from baseline at 3 months follow-up
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- 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.
Irina Timofte, MD, MS principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sirolimus 0.5 Mg Oral Tablet, Sirolimus 1Mg Oral Tablet and Sirolimus 2 MG Oral Tablet in people with Aging, run by University of Texas Southwestern Medical Center at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irina Timofte, MD, MS (2163347534, Irina.Timofte@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for Sirolimus (time frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose). The study lists 15 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 25 Jun 2026.