Ann Arbor, MINCT07220785Now EnrollingIRB Ready

Generalized Lipodystrophy Clinical Trial in Ann Arbor, MI

Access cutting-edge generalized lipodystrophy treatment through this clinical trial at a research site in Ann Arbor. Study-provided care at no cost to qualified participants.

Sponsored by Regeneron Pharmaceuticals

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Expert Care in Ann Arbor

Access generalized lipodystrophy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related generalized lipodystrophy treatment provided free

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Check if you qualify for this generalized lipodystrophy clinical trial in Ann Arbor, MI

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Why Participate?

  • No-Cost Study Care

  • Local to Ann Arbor

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Ann Arbor site if eligible
  4. 4Begin participation

About This Generalized Lipodystrophy Study in Ann Arbor

This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD). The aim of the study is to see how well mibavademab works and what side effects it has. Researchers will also look at how much mibavademab is in the body at different times. This is a 2-part study: Part A is an efficacy study in pediatric and adult participants, Part B is a safety and pharmacokinetic study in pediatric participants. The study is researching several other questions, including: * How mibavademab affects the amount of sugar in the blood * How mibavademab affects the amount of fat (triglycerides) in the blood * How mibavademab affects the amount of fat that has built up in the liver * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Sponsor: Regeneron Pharmaceuticals

Who Can Participate

Inclusion Criteria

1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines For Part A only:
Participants ≥2 years of age at screening
At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screening period)
Fasting TG ≥500 mg/dL
Fasting TG value of ≥300 mg/dL and the presence of another complication of GLD consistent with leptin deficiency (history of diabetes mellitus, hyperphagia, Metabolic Associated Fatty Liver Disease (MAFLD), polycystic ovary syndrome, etc)
Weight ≥15 kg at screening
Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting TG from at least 6 months prior to screening, as described in the protocol For Part B only:
Participants \<12 years of age at screening
Weighing ≥7 kg at screening
No metabolic criteria for study entry is required, as described in the protocol Key

Exclusion Criteria

Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus
Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol
eGFR of \<30 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or Schwartz equation, as applicable, at screening. Assessment can be repeated once
History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol
Treatment with over-the-counter or prescription medications with the intention of weight loss within 3 months prior to the screening visit For Part A only:
Treatment with metreleptin within 3 months of the screening visit
Addition or discontinuation of prescription medications or over-the-counter supplements for diabetes and/or dyslipidemia within 3 months prior to the start of the screening period, or changes in the use of these medications, as described in the protocol
Significant changes to lifestyle and diet, as described in the protocol
Current chronic treatment with high-dose corticosteroids, defined as use of higher than physiologic doses, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT07220785) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Generalized Lipodystrophy Treatment Options in Ann Arbor, MI

If you're searching for generalized lipodystrophy treatment options in Ann Arbor, MI, this clinical trial (NCT07220785) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced generalized lipodystrophy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all generalized lipodystrophy clinical trials near you to find additional studies recruiting in your area.

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