NCT06416969 Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation
| NCT ID | NCT06416969 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Adults who gain most of their excess weight in the abdominal area typically do not respond to factors that "turn on" fat cells the same way as people who don't have excessive weight. Researchers are trying to understand why fat tissue responds differently in people with different body types.
Eligibility Criteria
Inclusion Criteria: * Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo Clinical Research and Trials Unit for at least 3 days prior to study. * Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2 o Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT scan, usually with \> 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of \> 0.30, and/or biochemical evidence of metabolic syndrome as defined by adenosine triphosphate (ATP) III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of \>0.95 and/or increased visceral fat (visceral fat area \> 120 cm2 or a visceral/total fat abdominal ratio by CT of \> 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia. * Female subjects are eligible if they meet the following criteria: * Are not pregnant or nursing * All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug. * Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or \> than five half-lives of the compound, whichever is longer. If Yes look at consent form and f/u visits: * Current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude * Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks * Previous labs: * Fasting glucose \< 126 mg/dl for non-diabetic UBO * Hb ≥ 11.0 for women and ≥ 12 for men * platelets \> 100 000 Exclusion Criteria: * Individuals with a history of a disease process such as: * Ischemic heart disease * Atherosclerotic valvular disease * Persistent blood pressure greater than 160/95 despite antihypertensive medication * Peripheral artery disease * Any history of trans-ischemic attacks. * Coronary artery disease. * Liver cirrhosis * Significant renal impairment as documented in medical chart. * Smokers * Diagnosis of Diabetes Mellitus. * Concomitant use of medications that can alter free fatty acid metabolism or pose a drug-drug interaction: statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinedione; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; Linezolid; Dihydroergotamine; Phenelzine; daily phosphodiesterase inhibitors * Allergy to lidocaine * Allergy to indocyanine green.
Contact & Investigator
Michael Jensen, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06416969 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06416969 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06416969 currently recruiting?
Yes, NCT06416969 is actively recruiting participants. Contact the research team at reid.madeline@mayo.edu for enrollment information.
Where is the NCT06416969 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06416969 clinical trial?
NCT06416969 is sponsored by Mayo Clinic. The principal investigator is Michael Jensen, MD at Mayo Clinic. The trial plans to enroll 24 participants.
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