SmokersPhase 1NCT07058974
A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation
A Phase 1 study testing lamivudine, rapamycin and Exercise Regimen in people with Smokers and Former Smokers, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine supplementation, and either rapamycin or lamivudine. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Smokers, Former Smokers
- What is being tested?
- lamivudine, rapamycin and Exercise Regimen
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 15 Jun 2027
- Phase
- Phase 1
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60-85 years old
- Current or former smokers
- BMI 25-35
- No cancer requiring active therapy within the last 2 years
- No autoimmune disease requiring disease modifying agents
- No patients with EGFR <30 or ESRD
- No class 3 or 4 heart failure
Who cannot join
- Patients may not have cancer requiring active therapy within the last 2 years
- Patients may not have autoimmune disease requiring disease modifying agents
- Patients may not be receiving immune modifying biologic therapies
- Patients may not have chronic kidney disease stage 3/4 or end stage renal disease
- Patients may not have a known history of metabolic dysfunction-associated steatohepatitis
- Patients may not have a known chronic viral infection such as HIV or active Hepatitis B or C, or a known history of genital HSV. Patients who have spontaneously or through treatment cleared hepatitis B or C are candidates for the trial. If Hepatitis B core ab is positive must document a negative PCR.
Show all 21Show fewer
- Patients may not have class 3 or 4 heart failure, or have experienced a myocardial infarction or cerebrovascular event in the past 6 months
- Patients may not have uncontrolled diabetes mellitus
- Patients may not have a history of clinically significant interstitial lung disease (ILD).
- Patients may not have clinically significant active wound healing due to recent injury or surgery
- Patients may not have signs or symptoms of clinically significant acute infectious illness on screening laboratory testing or physical examination.
- Patients may not have evidence of active or latent tuberculosis
- Patients may not have nephrotic range proteinuria on screening labs
- Patients may not have received a live virus within one month of study initiation.
- Patients cannot have uncontrolled hypertension (persistent systolic >160; diastolic >100)
- Patients with an inherited primary immunodeficiency
- Patients may not have a history of, or current evidence of, clinically significant chronic liver disease
- Patients may not be receiving any chronic immunosuppressive therapy.
- Patients may not be receiving medications that could increase rapamycin blood concentrations, such as strong inhibitors and inducers of CYP3A4 and/or P-gp (ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin; rifampin or rifabutin), bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors, metoclopramide, nicardipine, troleandomycin, verapamil. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
- Patients may not be receiving medications that could decrease rapamycin blood concentrations, such as: carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
- Patients may not be receiving medications known to cause angioedema with concomitant use of rapamycin, such as angiotensin-converting enzyme (ACE) inhibitors. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Multi-cohort Clinical Trial Assessing Safety and Feasibility of Exercise and Spermidine Administered in Conjunction With Lamivudine (RTi) or Rapamycin (mTORi) to Assess Impact on Dynamic Changes of Inflammation and Aging
This is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine supplementation, and either rapamycin or lamivudine.
- Conditions
- Smokers, Former Smokers
- Being tested
- lamivudine, rapamycin, Exercise Regimen, Spermidine
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamivudineDrug
Also called Epivir
Lamivudine (Epivir) is a drug used typically to treat HIV and Hepatitis B Virus (HBV). It has not been studied when given in combination with spermidine.
rapamycinDrug
Also called Rapamune, Sirolimus
Rapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator.
Exercise RegimenBehavioural
All experimental groups will receive an exercise regimen combining high-intensity interval training (HIIT) (targeting aerobic fitness) and resistance training (targeting strength and skeletal muscle mass preservation). The HIIT exercise component will consist of 2 sessions per week totaling 20 minutes per session. The resistance training component will consist of 3 sessions per week totaling 40 minutes per session.
SpermidineDietary supplement
Spermidine is a polyamine that forms naturally in plants, animals, and microorganisms as a byproduct of protein breakdown. Participants will take an oral dosage of 2mg/day for 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and spermidine administered in conjunction with lamivudine (RTi) | Experimental | Participants will perform an exercise regimen and take spermidine and lamivudine for 180 days. Receives: Drug: lamivudine; Behavioral: Exercise Regimen; Dietary Supplement: Spermidine |
| Exercise and spermidine administered in conjunction with rapamycin (mTORi) | Experimental | Participants will perform an exercise regimen and take spermidine and rapamycin for 180 days. Receives: Drug: rapamycin; Behavioral: Exercise Regimen; Dietary Supplement: Spermidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0. Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Any patient experiencing a Grade 3 or 4 adverse event must hold drug until toxicity returns to grade 0-1. The treating investigator may hold study drug for any duration if the patient is deemed to be experiencing a Grade 1-2 adverse event related to study drug.
Measured: at 180 days
Number of participants with ability to complete >80% of specified pharmacological intervention
Feasibility of the trial is determined by participant documentation of taking at least 80% of the provided study drug on a regular basis, ability to complete >80% of specified pharmacological intervention.
Measured: at 180 days
Secondary outcomes (1)
Neutrophil to lymphocyte ratio (NLR)
Measure NLR from complete blood count.
Measured: at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start12 Aug 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Marron, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Marron, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058974
- Sponsor's protocol ID
- STUDY-24-01678
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multi-cohort Clinical Trial Assessing Safety and Feasibility of Exercise and Spermidine Administered in Conjunction With Lamivudine (RTi) or Rapamycin (mTORi) to Assess Impact on Dynamic Changes of Inflammation and Aging
- ClinicalTrials.gov ID
- NCT07058974
- Acronym / sponsor ID
- STUDY-24-01678
- Conditions
- Smokers, Former Smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 10 Jul 2025 (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 is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine supplementation, and either rapamycin or lamivudine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and spermidine administered in conjunction with lamivudine (RTi) | Experimental | Drug: lamivudine, Behavioral: Exercise Regimen, Dietary Supplement: SpermidineParticipants will perform an exercise regimen and take spermidine and lamivudine for 180 days. |
| Exercise and spermidine administered in conjunction with rapamycin (mTORi) | Experimental | Drug: rapamycin, Behavioral: Exercise Regimen, Dietary Supplement: SpermidineParticipants will perform an exercise regimen and take spermidine and rapamycin for 180 days. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 60-85 years old
- Current or former smokers
- BMI 25-35
- No cancer requiring active therapy within the last 2 years
- No autoimmune disease requiring disease modifying agents
Key exclusion criteria (21 listed)
- Patients may not have cancer requiring active therapy within the last 2 years
- Patients may not have autoimmune disease requiring disease modifying agents
- Patients may not be receiving immune modifying biologic therapies
- Patients may not have chronic kidney disease stage 3/4 or end stage renal disease
- Patients may not have a known history of metabolic dysfunction-associated steatohepatitis
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 |
|---|---|---|
| lamivudineAlso: EpivirLamivudine (Epivir) is a drug used typically to treat HIV and Hepatitis B Virus (HBV). It has not been studied when given in combination with spermidine. | Drug | Exercise and spermidine administered in conjunction with lamivudine (RTi) |
| rapamycinAlso: Rapamune, SirolimusRapamycin (Rapamune, Sirolimus) is an FDA-approved drug and indicated for use as an immune modulator. | Drug | Exercise and spermidine administered in conjunction with rapamycin (mTORi) |
| Exercise RegimenAll experimental groups will receive an exercise regimen combining high-intensity interval training (HIIT) (targeting aerobic fitness) and resistance training (targeting strength and skeletal muscle mass preservation). The HIIT exercise component will consist of 2 sessions per week totaling 20 minutes per session. The resistance training component will consist of 3 sessions per week totaling 40 minutes per session. | Behavioural | Exercise and spermidine administered in conjunction with lamivudine (RTi), Exercise and spermidine administered in conjunction with rapamycin (mTORi) |
| SpermidineSpermidine is a polyamine that forms naturally in plants, animals, and microorganisms as a byproduct of protein breakdown. Participants will take an oral dosage of 2mg/day for 180 days. | Dietary supplement | Exercise and spermidine administered in conjunction with lamivudine (RTi), Exercise and spermidine administered in conjunction with rapamycin (mTORi) |
Primary outcome
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0
Time frame: at 180 days
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0. Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Any patient experiencing a Grade 3 or 4 adverse event must hold drug until toxicity returns to grade 0-1. The treating investigator may hold study drug for any duration if the patient is deemed to be experiencing a Grade 1-2 adverse event related to study drug.
Number of participants with ability to complete >80% of specified pharmacological intervention
Time frame: at 180 days
Feasibility of the trial is determined by participant documentation of taking at least 80% of the provided study drug on a regular basis, ability to complete >80% of specified pharmacological intervention.
1 secondary outcome
Neutrophil to lymphocyte ratio (NLR)
Time frame: at 180 days
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Smokers
Active, not recruiting
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment
Depression, Tobacco Use Disorder
Recruiting
Vaped Phenanthrene
Former Smoker, Non-Smoker
RecruitingPhase 1
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease
Healthy, Healthy Smoker
RecruitingEarly Phase 1
Psilocybin as a Treatment for Chronic Pain in Smokers
Smokers With Chronic Pain
Active, not recruiting
Physical Activity in Promoting Smoking Cessation in African Americans
Current Smoker, Healthy Subject
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.
Thomas Marron, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lamivudine, rapamycin and Exercise Regimen in people with Smokers and Former Smokers, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 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 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.
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?
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?
Number and Type of Grade 3/4 Adverse Events per CTCAE Version 5.0 (time frame: at 180 days). 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 27 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.