Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy

Conditions

• Generalized Lipodystrophy

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mibavademab — DRUG
  Administered as per the protocol
• Placebo — DRUG
  Administered as per the protocol

Study Details

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)

Key Dates

Start date

Mar 13, 2026

Status verified

May 2026

Primary completion

May 19, 2028

Completion

Sep 8, 2028

Study Design

Enrollment

28 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Arm A
• Experimental: Part A: Arm B
• Experimental: Part A: Arm C
• Placebo Comparator: Part A: Arm D
• Experimental: Part B

Primary Outcome Measure

Change in Hemoglobin A1c (HbA1c) [ Time Frame: Through 36 weeks of exposure to mibavademab ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (2)

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