Gemfibrozil

Generic Name: Gemfibrozil

Brand Names: Lopid

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₂O_₃

CAS Number: 25812-30-0

Unique Ingredient Identifier: Q8X02027X3

Background: Gemfibrozil is a fibric acid agent, similar to clofibrate, used to treat Type IIb, IV, and V hyperlipidemias. Gemfibrozil is not a first line treatment and is prescribed to patients who have not responded adequately to weight loss, diet, exercise, and other medications.

Gemfibrozil was granted FDA approval on 21 December 1981.

Indication: Gemfibrozil is indicated to treat patients with Types IV and V hyperlipidemia who have elevated serum triglycerides (usually above 2000mg/dL), elevated VLDL cholesterol, fasting chylomicrons, are at risk of developing pancreatitis, and do not adequately respond to dietary restrictions. Gemfibrozil is also indicated to reduce the risk of developing coronary heart disease in patients with Type IIb hyperlipidemia without history or symptoms of coronary heart disease; who do not adequately respond to weight loss, diet, exercise, and other medications; and have low HDL, raised LDL, and raised triglycerides.

Associated Conditions: Coronary Heart Disease (CHD), Fredrickson classification type IV Hyperlipidemia, Fredrickson classification type V Hyperlipidemia

Clinical Trials

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

Phase 1

Completed

Conditions: Drug-drug Interaction

Interventions: Drug: tucatinib
Drug: repaglinide
Drug: itraconazole
Drug: rifampin
Drug: gemfibrozil
Drug: digoxin
Drug: tolbutamide
Drug: midazolam

First Posted Date: 2018-10-29

Last Posted Date: 2019-12-18

Lead Sponsor: Seagen Inc.

Target Recruit Count: 116

Registration Number: NCT03723395

Locations: 🇺🇸
Covance Clinical Research Unit, Dallas, Texas, United States

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Ozanimod
Drug: Gemfibrozil
Drug: Itraconazole
Drug: Rifampin

First Posted Date: 2018-08-10

Last Posted Date: 2019-05-30

Lead Sponsor: Celgene

Target Recruit Count: 100

Registration Number: NCT03624959

Locations: 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States

Exploration of Gemfibrozil as a Treatment for AUD

Phase 2

Terminated

Conditions: Alcohol Use Disorder

Interventions: Drug: Gemfibrozil 600 MG
Drug: Placebo oral capsule

First Posted Date: 2018-05-29

Last Posted Date: 2021-10-29

Lead Sponsor: The Mind Research Network

Target Recruit Count: 3

Registration Number: NCT03539432

Locations: 🇺🇸
The Mind Research Network, Albuquerque, New Mexico, United States

Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma

Phase 1

Terminated

Conditions: Cholangiocarcinoma Non-resectable
Cholangiocarcinoma, Intrahepatic
Cholangiocarcinoma, Extrahepatic
Gallbladder Adenocarcinoma

Interventions: Drug: PEGPH20
Drug: CIS
Drug: GEM
Drug: Atezolizumab

First Posted Date: 2017-08-31

Last Posted Date: 2020-02-07

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 85

Registration Number: NCT03267940

Locations: 🇺🇸
Gabrail Cancer Center, Canton, Ohio, United States
🇺🇸
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 33 locations