ObesityPhase 2/3NCT05653258
Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects
A Phase 2/3 study testing Lifestyle Intervention, Dasatinib 100 MG and Quercetin 1000mg in people with Obesity and Healthy Lifestyle, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq and metabolic/physiological assessments (insulin sensitivity, glucose tolerance, and β-cell function). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Healthy Lifestyle
- What is being tested?
- Lifestyle Intervention, Dasatinib 100 MG and Quercetin 1000mg
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 1 Feb 2028
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both Sexes
- Age: younger lean group 18-30 years with BMI 18.5-24.9 kg/m2; younger obese group 18-30 with BMI 30.0 -39.9; older obese group ≥ 65 years with BMI 30.0-39.9
- All races and ethnic groups
- Community dwelling
- Sedentary (≤1.5 h of exercise per week)
- Nondiabetic (fasting plasma glucose < 126 mg/dl, 2-h glucose during oral glucose tolerance test (OGTT) < 140mg/dl, and A1c < 6.5%
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- For all female participants who are women of childbearing potential (WOCBP), who are not pregnant or breast feeding, at least one of the following conditions must apply:
- A documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy Use of a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency (implantable progesterone-only hormone contraception, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner) during the intervention period of the study and for at least 30 days after the last dose of study intervention to eliminate any reproductive safety risk of the study drug.
- Use of a contraceptive method that is highly effective (with a failure rate of <1% per year), with high user dependency, (oral/intravaginal/injectable combined estrogen and progesterone contraception, oral/injectable progesterone only hormone contraception, sexual abstinence) during the intervention period and for at least 30 days after the last dose of study intervention to eliminate any reproductive safety risk of the study drug. In addition to the highly effective methods: male or female condom with or without spermicide; cervical cap, diaphragm, or sponge with spermicide; a combination of male condom with either cervical cap, diaphragm, or sponge with spermicide.
- ECG value after 10 minutes of resting in the supine position in the following ranges:
- 120ms<PR<220ms: QRS<120ms; QTc<430ms for males and QTc<450ms for females and normal ECG tracing, unless the investigator considers the ECG abnormality to be not clinically relevant.
Who cannot join
- Diabetes, clinically diagnosed or HbA1c > 6.5% and/or fasting plasma glucose > 126 mg/dl and/or use of anti-diabetic medications.
- Participating in > 1.5 h of structured exercise/week
- Unstable weight (>3% change in last 3 months)
- Neurological, musculoskeletal, or other conditions that may limit subject's ability to complete study physical assessment and training
- Active autoimmune/inflammatory disease including: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematous, inflammatory bowel disease
- Laboratory parameters outside the normal range:
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- impaired kidney function (eGFR < 30ml/min/1.73m² as calculated by the CKD-EPI equation);
- impaired liver function (AST or ALT level > 2 times upper limit of normal (ULN);
- total Bilirubin level > 1.5 times ULN;
- TSH > 1.5 times ULN or < lower limit of normal (LLN);
- Hemoglobin <10.0 g/dl; Platelets <125,000 cell/mm³;
- Platelets < 125,000 cell/mm³
- Prothrombin time (PT) > 1.0 times ULN
- Partial prothrombin time (PTT) > 1.0 times ULN.
- Active gastrointestinal disease; coagulopathy; GI bleed within 6 months
- Clinically significant heart disease (e.g. NYH Classification >II; ischemia)
- Peripheral vascular disease (claudication)
- QTc prolongation >45 msec
- Use of anti-arrhythmic medications known to cause QTc prolongation, anti-platelet or anti-coagulant medication (see section 5.3)
- Use of quinolone antibiotics or any other drugs that may prolong the QTc interval (see section 5.3)
- Pulmonary disease (COPD), severe asthma or exercise-induced asthma
- Recent systemic or pulmonary embolus
- Uncontrolled blood pressure (systolic BP>170, diastolic BP>95 mmHg)
- Smoking, alcohol use (history of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants. 1 drink = 5 ounces [150ml] of wine or 12 ounces [360ml] of beer or 1.5 ounces [45ml] of hard liquor) or recreational drug use (other than marijuana)
- Pregnant or breastfeeding
- Postmenopausal women new (within 6 months) to systemic hormone replacement therapy
- Previous bariatric surgery
- History of stroke with motor disability
- Recent (3 years) treated cancer other than basal cell carcinoma
- Acute or chronic infection
- Medication that might interfere with metabolic studies (weight loss medication, systemic steroids, immunosuppressants) within 6 months (see section 5.3)
- Potentially senolytic agents within the last 6 months: fisetin, quercetin, luteolin, dasatinib, piperlongumine, or navitoclax (see section 5.3)
- History of allergy to dasatinib, quercetin and/or lidocaine.
- Concurrent enrollment in another interventional trial.
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
Cedars Sinai Medical Center
Los Angeles, California, 90048
Nicolas Musi, 12106305001, nicolas.musi@cshs.org
Sandra Gomez, 210-777-0629, Sandra.Gomez3@cshs.org
About this study
Official title: Single Nuclei RNA-sequencing to Map Adipose Cellular Populations and Senescent Cells in Older Subjects
All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq and metabolic/physiological assessments (insulin sensitivity, glucose tolerance, and β-cell function). Older obese participants will be randomized into three arms: lifestyle intervention (n=24), senolytics (n=24), or placebo (n=24).
Read the detailed description
All participants after consent and enrollment will undergo adipose tissue single nuclei RNA sequencing and metabolic phenotyping. Subjects will undergo glucose tolerance testing to document glucose tolerance status. Each subject will be provided an accelerometer to be worn on their dominant wrist for 7 days for assessment of habitual activity.
A dietitian will teach them to utilize the SmartIntake3 smartphone food picture application (app) for a 7-day food record. The app will be used to record amount of each meal consumed in order to determine daily food and beverage and supplement intake and quantity for dietary composition analysis. DEXA analysis will be performed to measure lean and fat body mass.
Subjects will undergo evaluation of physical function/performance, including the Short Physical Performance Battery (SPPB) and VO2 peak testing for assessment of aerobic capacity. The SPPB will be done in older adults only.
The NIH Patient-Reported Outcomes Measurement System (PROMIS) will be used to measure participants' self-report of symptoms, function, and health-related quality of life in the domains of physical, mental and social health.
All subjects will undergo a two-step euglycemic insulin clamp and indirect calorimetry.
Only older obese participants will continue to the randomization to likestyle intervention, senolytic agents or placebo.
- Conditions
- Obesity, Healthy Lifestyle
- Being tested
- Lifestyle Intervention, Dasatinib 100 MG, Quercetin 1000mg, Placebo, Abdominal adipose tissue biopsy
- Keywords
- Lifestyle intervention, Single RNA sequencing, Cell Senescence
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionOther
Also called Exercise and Diet
- Exercise: Subjects will undergo a combined aerobic and resistance exercise intervention. The investigators propose a multi-modal training program because they improve metabolic outcomes and adding resistance training reduces the risk of muscle loss during weight loss. Subjects will exercise in the gym for three sessions per week for 10 weeks under supervision of an exercise physiologist. On each session, aerobic exercise will be followed by resistance exercise.
- Diet: The aim of the dietary intervention is to reduce caloric intake sufficient to result in 8-10% weight loss, while incorporating behavioral and dietary strategies to maximize adherence and to minimize risk of muscle and bone loss. Subjects will attend small-group sessions led by a dietitian for changing their dietary composition to follow American Heart Association (AHA)/American College of Cardiology (ACC) guidelines.
Dasatinib 100 MGDrug
Also called Sprycell
100 mg of dasatinib (D) daily for 3 consecutive days plus quercetin (Q) for the same 3 consecutive days, followed by a 25-day (+/- 2 day) no-drug period to complete a single round. This will be repeated twice more until completing 3 rounds total in approximately 10 consecutive weeks.
Quercetin 1000mgDrug
Quercetin (Q) (4) 250 mg capsules daily (total 1000 mg daily) plus dasatinib (D) same 3 consecutive days, followed by a 25-day (+/- 2 day) no-drug period to complete a single round. This will be repeated twice more until completing 3 rounds total in approximately 10 consecutive weeks.
PlaceboDrug
Also called Placebo capsule
Subjects will receive a placebo (methylcellulose) to provide a similar mass, number of tablets/ capsules, and frequency as the senolytic arm.
Abdominal adipose tissue biopsyProcedure or surgery
Also called Subcutaneous abdominal adipose tissue biopsy
All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq
| Study group | Role | What they receive |
|---|---|---|
| Younger Lean Group | Other | Participants will be aged 18-30 years and have a BMI of 18.5 - 24.9 kg/m2 Receives: Procedure: Abdominal adipose tissue biopsy |
| Older Lean Group | Other | Participants will be over 65 years of age with a BMI of 18.5 to 24.9 kg/m2 Receives: Procedure: Abdominal adipose tissue biopsy |
| Older Obese Group | Experimental | Participants will be over 65 years of age with a BMI of 30-39.9 kg/m2. Receives: Other: Lifestyle Intervention; Drug: Dasatinib 100 MG; Drug: Quercetin 1000mg; Drug: Placebo; Procedure: Abdominal adipose tissue biopsy |
| Younger Obese Group | Experimental | Participants will be ages 18-30 years and have a BMI OF 30.0-39.9 kg/m2 Receives: Procedure: Abdominal adipose tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Change in skeletal muscle insulin sensitivity
Measured: Week 4 and Week 15
Glucose tolerance
Measurement of change in glucose tolerance using a glucose tolerance test
Measured: Baseline to Week 14
Secondary outcomes (1)
Senescence-associated secretory phenotype (SASP)
Measurement of change of SASP in adipose tissue
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start17 Oct 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will undergo cellular/molecular profiling and older obese participants will be randomized into 3 arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nicolas Musi, MD, Cedars-Sinai Medical Center
- Investigators
- Nicolas Musi, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653258
- Sponsor's protocol ID
- STUDY00002506
- Other IDs
- R01AG075684
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified data will be shared Research findings will be published in peer-reviewed scientific journals and will be presented at scientific meetings. Data derived from this study will be available upon request to regulatory bodies including NIH, UTHSCSA, DSMB, and the IRB.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Nuclei RNA-sequencing to Map Adipose Cellular Populations and Senescent Cells in Older Subjects
- ClinicalTrials.gov ID
- NCT05653258
- Acronym / sponsor ID
- STUDY00002506
- Conditions
- Obesity, Healthy Lifestyle
- Keywords
- Lifestyle intervention, Single RNA sequencing, Cell Senescence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 16 Dec 2022 (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.
All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq and metabolic/physiological assessments (insulin sensitivity, glucose tolerance, and β-cell function). Older obese participants will be randomized into three arms: lifestyle intervention (n=24), senolytics (n=24), or placebo (n=24).
Detailed description
All participants after consent and enrollment will undergo adipose tissue single nuclei RNA sequencing and metabolic phenotyping. Subjects will undergo glucose tolerance testing to document glucose tolerance status. Each subject will be provided an accelerometer to be worn on their dominant wrist for 7 days for assessment of habitual activity.
A dietitian will teach them to utilize the SmartIntake3 smartphone food picture application (app) for a 7-day food record. The app will be used to record amount of each meal consumed in order to determine daily food and beverage and supplement intake and quantity for dietary composition analysis. DEXA analysis will be performed to measure lean and fat body mass.
Subjects will undergo evaluation of physical function/performance, including the Short Physical Performance Battery (SPPB) and VO2 peak testing for assessment of aerobic capacity. The SPPB will be done in older adults only.
The NIH Patient-Reported Outcomes Measurement System (PROMIS) will be used to measure participants' self-report of symptoms, function, and health-related quality of life in the domains of physical, mental and social health.
All subjects will undergo a two-step euglycemic insulin clamp and indirect calorimetry.
Only older obese participants will continue to the randomization to likestyle intervention, senolytic agents or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- All participants will undergo cellular/molecular profiling and older obese participants will be randomized into 3 arms.
| Arm | Type | Receives |
|---|---|---|
| Younger Lean Group | Other | Procedure: Abdominal adipose tissue biopsyParticipants will be aged 18-30 years and have a BMI of 18.5 - 24.9 kg/m2 |
| Older Lean Group | Other | Procedure: Abdominal adipose tissue biopsyParticipants will be over 65 years of age with a BMI of 18.5 to 24.9 kg/m2 |
| Older Obese Group | Experimental | Other: Lifestyle Intervention, Drug: Dasatinib 100 MG, Drug: Quercetin 1000mg, Drug: Placebo, Procedure: Abdominal adipose tissue biopsyParticipants will be over 65 years of age with a BMI of 30-39.9 kg/m2. |
| Younger Obese Group | Experimental | Procedure: Abdominal adipose tissue biopsyParticipants will be ages 18-30 years and have a BMI OF 30.0-39.9 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Both Sexes
- Age: younger lean group 18-30 years with BMI 18.5-24.9 kg/m2; younger obese group 18-30 with BMI 30.0 -39.9; older obese group ≥ 65 years with BMI 30.0-39.9
- All races and ethnic groups
- Community dwelling
- Sedentary (≤1.5 h of exercise per week)
Key exclusion criteria (34 listed)
- Diabetes, clinically diagnosed or HbA1c > 6.5% and/or fasting plasma glucose > 126 mg/dl and/or use of anti-diabetic medications.
- Participating in > 1.5 h of structured exercise/week
- Unstable weight (>3% change in last 3 months)
- Neurological, musculoskeletal, or other conditions that may limit subject's ability to complete study physical assessment and training
- Active autoimmune/inflammatory disease including: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematous, inflammatory bowel 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 |
|---|---|---|
| Lifestyle InterventionAlso: Exercise and Diet1. Exercise: Subjects will undergo a combined aerobic and resistance exercise intervention. The investigators propose a multi-modal training program because they improve metabolic outcomes and adding resistance training reduces the risk of muscle loss during weight loss. Subjects will exercise in the gym for three sessions per week for 10 weeks under supervision of an exercise physiologist. On each session, aerobic exercise will be followed by resistance exercise. 2. Diet: The aim of the dietary intervention is to reduce caloric intake sufficient to result in 8-10% weight loss, while incorporating behavioral and dietary strategies to maximize adherence and to minimize risk of muscle and bone loss. Subjects will attend small-group sessions led by a dietitian for changing their dietary composition to follow American Heart Association (AHA)/American College of Cardiology (ACC) guidelines. | Other | Older Obese Group |
| Dasatinib 100 MGAlso: Sprycell100 mg of dasatinib (D) daily for 3 consecutive days plus quercetin (Q) for the same 3 consecutive days, followed by a 25-day (+/- 2 day) no-drug period to complete a single round. This will be repeated twice more until completing 3 rounds total in approximately 10 consecutive weeks. | Drug | Older Obese Group |
| Quercetin 1000mgQuercetin (Q) (4) 250 mg capsules daily (total 1000 mg daily) plus dasatinib (D) same 3 consecutive days, followed by a 25-day (+/- 2 day) no-drug period to complete a single round. This will be repeated twice more until completing 3 rounds total in approximately 10 consecutive weeks. | Drug | Older Obese Group |
| PlaceboAlso: Placebo capsuleSubjects will receive a placebo (methylcellulose) to provide a similar mass, number of tablets/ capsules, and frequency as the senolytic arm. | Drug | Older Obese Group |
| Abdominal adipose tissue biopsyAlso: Subcutaneous abdominal adipose tissue biopsyAll participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq | Procedure or surgery | Older Lean Group, Older Obese Group, Younger Lean Group, Younger Obese Group |
Primary outcome
Insulin sensitivity
Time frame: Week 4 and Week 15
Change in skeletal muscle insulin sensitivity
Glucose tolerance
Time frame: Baseline to Week 14
Measurement of change in glucose tolerance using a glucose tolerance test
1 secondary outcome
Senescence-associated secretory phenotype (SASP)
Time frame: Baseline to Week 16
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 18 Mar 2026.
- Individual participant dataSharing planned: Yes. Unidentified data will be shared Research findings will be published in peer-reviewed scientific journals and will be presented at scientific meetings. Data derived from this study will be available upon request to regulatory bodies including NIH, UTHSCSA, DSMB, and the IRB.
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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.
Nicolas Musi, MD principal investigator
Cedars-Sinai 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 2/3 study testing Lifestyle Intervention, Dasatinib 100 MG and Quercetin 1000mg in people with Obesity and Healthy Lifestyle, run by Cedars-Sinai 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 11 inclusion and 34 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 18 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Nicolas Musi, MD (210-562-6140, nicolas.musi@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Week 4 and Week 15). 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 18 Mar 2026.