Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06416969

Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

Led by Mayo Clinic · Updated on 2025-12-24

24

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females between 18 and 65 years of age who understand instructions and agree to follow study procedures
  • Willingness to sign informed consent and consume an isoenergetic diet provided by Mayo Clinical Research and Trials Unit for at least 3 days before the study
  • Overweight or obese volunteers with a BMI between 29.0 and 40.0 kg/m2
  • Women with upper body/visceral obesity defined by waist-hip ratio > 0.85 or visceral fat > 120 cm2 by CT scan or metabolic syndrome by ATP III criteria
  • Men with upper body obesity defined by waist-hip ratio > 0.95 or visceral fat area > 120 cm2 by CT scan or metabolic syndrome by ATP III criteria
  • Female participants must not be pregnant or nursing
  • Women of childbearing potential must have negative urine pregnancy tests at screening and within 48 hours before study drug administration
  • No recent participation in other investigational drug studies within 12 weeks or more than five half-lives of the compound
  • No current use of medications that affect fatty acid or adipose metabolism
  • Fasting glucose < 126 mg/dL for non-diabetic upper body obese volunteers
  • Hemoglobin ≥ 11.0 for women and ≥ 12 for men
  • Platelet count > 100,000
Not Eligible

You will not qualify if you...

  • History of ischemic heart disease, atherosclerotic valvular disease, or peripheral artery disease
  • Persistent high blood pressure (>160/95) despite medication
  • Any history of trans-ischemic attacks or coronary artery disease
  • Liver cirrhosis or significant kidney impairment
  • Current smokers
  • Diagnosis of diabetes mellitus
  • Use of medications that alter free fatty acid metabolism or cause drug interactions (e.g., statins without provider approval, niacin, fibrates, thiazolidinedione, beta-blockers, corticosteroids, anabolic steroids, linezolid, dihydroergotamine, phenelzine, daily phosphodiesterase inhibitors)
  • Allergies to lidocaine or indocyanine green

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

Loading map...

Research Team

M

Madeline Reid

CONTACT

K

Kelli Lytle, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here