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New treatment option for Obesity
Official title Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects
ClinicalTrials.gov ID: NCT05653258
What this study is testing
What is Dasatinib 100 MG?
Dasatinib 100 MG is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for obesity.
Also referred to as Sprycell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- All races and ethnic groups
- Community dwelling
- Sedentary (≤1.5 h of exercise per week)
You likely can't join if
- 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:
See the full eligibility criteria
- 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%
- 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...
- 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...
- 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:
- 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...
- 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 treatment trial.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.