A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) (LEAP)

  • STATUS
    Recruiting
  • End date
    Feb 6, 2024
  • participants needed
    40
  • sponsor
    Regeneron Pharmaceuticals
Updated on 13 April 2022

Summary

Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL

The primary objectives will be evaluated for patients in Cohort A only:

  • To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
  • To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)

The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:

  • To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
  • To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia

The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:

  • To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
  • To evaluate the effect of REGN4461 on hunger
  • To evaluate safety and tolerability of REGN4461
  • To characterize the concentration profile of REGN4461 over time
  • To assess immunogenicity to REGN4461

Details
Condition Familial Partial Lipodystrophy, Metabolic Abnormalities
Treatment Matching Placebo, REGN4461
Clinical Study IdentifierNCT05088460
SponsorRegeneron Pharmaceuticals
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)
No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol

Exclusion Criteria

Treatment with metreleptin within 3 months of the screening visit
Patients with a diagnosis of generalized lipodystrophy
Patients with a diagnosis of acquired lipodystrophy
Pregnant or breastfeeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note