Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

Conditions

• Type 1 Hyperlipoprotenemia

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Orlistat — DRUG
  Orlistat is an inhibitor of gastric and pancreatic lipases and can reduce dietary fat absorption by 30%. Orlistat at a dose of 2 capsules (each containing 60 mg of active drug) three times a day with each meal (a total dose of 360 mg daily).
• Placebo — DRUG
  Placebo at a dose of 2 capsules (each containing 60 mg placebo) three times a day with each meal (a total dose of 360 mg daily).

Study Details

Type I hyperlipoproteinemia (T1HLP, also known as familial chylomicronemia syndrome or FCS) is a rare diseasewhere the blood triglycerides (fats) are very high. It is caused by lack of certain enzymes and proteins in the bodythat are important in disposing circulating fats from blood. Treatment of T1HLP patients who have very high levels of blood fats (≥ 1,000 mg/dL) is challenging as conventional triglyceride-lowering medications, such as fibrates and fishoil, are ineffective. The purpose of this trial is to study the long-term efficacy and safety of orlistat for reducing blood triglyceride levels in patients with T1HLP.

Key Dates

Start date

Jan 26, 2024

Status verified

May 2025

Primary completion

Aug 1, 2027

Completion

May 30, 2029

Study Design

Enrollment

28 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Orlistat Drug
  Drug will be given orally.
• Placebo Comparator: Placebo
  Placebo will be given orally.

Primary Outcome Measure

Change in Triglycerides [ Time Frame: 24 weeks ]

Central Contacts

• Abhimanyu G [agarg], MD
  2146482895
  [email protected]
• Abhimanyu G [agarg]
  2146482895
  [email protected]

Locations (1)

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