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

ConditionGeneralized Lipodystrophy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorRegeneron Pharmaceuticals

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

HbA1c ≥7%

Fasting TG ≥500 mg/dL

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mibavademab

    Drug

    Administered as per the protocol

  • Placebo

    Drug

    Administered as per the protocol

Treatment groups

28 Participants
are divided into 5 treatment groups
Group A: Part A: Arm AExperimental treatment 1 intervention
Group B: Part A: Arm BExperimental treatment 2 interventions
Group C: Part A: Arm CExperimental treatment 1 intervention
Group D: Part A: Arm DPlacebo comparator 1 intervention
Group E: Part BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hemoglobin A1c (HbA1c)

Part A

Time frame
Through 36 weeks of exposure to mibavademab
2

Percent change in fasting Triglycerides (TG)

Part A

Time frame
Through 36 weeks of exposure to mibavademab
3

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Part B

Time frame
Up to 15 months
4

Severity of TEAEs

Part B

Time frame
Up to 15 months

Secondary outcomes

1

Change in HbA1c compared to placebo

Part A

Time frame
From baseline to week 20
2

Change in HbA1c compared to placebo

Part A

Time frame
From week 56 to week 64
3

Change in HbA1c

Part B

Time frame
From baseline to week 52
4

Percent change in fasting TG compared to placebo

Part A

Time frame
From baseline to week 20

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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