A study to examine the effects of the LEPR Agonist Antibody REGN4461 in patients with Familial Partial Lipodystrophy

Phase 1

• Conditions: Familial Partial Lipodystrophy; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; MedDRA version: 21.1Level: PTClassification code 10053857Term: Partial lipodystrophySystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2021-000138-33-ES
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-15
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female, >/= 18 years of age at the screening visit.
2. Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
3. Fasting leptin level <=20ng/ml, as determined during the screening period
4. Presence of significant metabolic abnormalities as defined in the protocol
5. Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
6. Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Adkins, Paleo, Vegetarianism, Veganism).
7. No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol

NOTE: Other protocol defined inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Treatment with metreleptin within 3 months of the screening visit
2. Patients with a diagnosis of generalized lipodystrophy
3. Patients with a diagnosis of acquired lipodystrophy
4. Pregnant or breastfeeding women

NOTE: Other protocol defined exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified