Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females

NCT03615534 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1 Al-KindyCM
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 2

Brief Summary

Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and type 2 diabetes mellitus and has emerged as an important marker for the increased cardiovascular disease (CVD) risk observed in these populations. Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent studies have focused on optimizing treatment for AD and compare the efficacy and tolerability of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach has not yet been established. The present study was intended to evaluate the restorative efficacy of Extended Release Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their safety and tolerability in females with obesity-induced AD.

Conditions

Atherogenic Dyslipidemia; Obesity Associated Disorder

Keywords

Extended Release Niacin; Fenofibrate; treatment; Obesity; Atherogenic Dyslipidemia

Outcome Measures

Primary Outcomes (3)

• Changes Serum Triglyceride Levels

  Assessments involve the measurement of serum Triglyceride (TG) level.

  Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.

• Changes in Serum Lipoprotein Cholesterol Levels

  Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels. Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC.

  Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.

• Changes in Serum Apolipoprotein Levels

  Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.

  Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.

Secondary Outcomes (6)

• Changes in Serum Fasting Glucose Levels.

  Changes from baseline were assessed at the end eighth week of treatments.

• Changes in Estimated Glomerular Filtration Rate (eGFR)

  Changes from baseline were assessed at the end of the eighth week of treatments.

• Changes in Serum Uric Acid Levels

  Changes from baseline were assessed at the end of the eighth week of treatments.

• Changes in Serum Enzymes Levels

  Changes from baseline were assessed at the end of the eighth week of treatments.

• Changes in Systolic and Diastolic Blood Pressure

  Changes from baseline were assessed at the end of the eighth week of treatments.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch daily single placebo capsule for eight weeks.

Other: Therapeutic Lifestyle Changes; Other: Placebo

Fenofibrate Monotherapy

ACTIVE COMPARATOR

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate (Lipanthyl® 200 mg micronized fenofibrate capsule, Abbott Laboratories Fournier) for eight weeks.

Other: Therapeutic Lifestyle Changes; Drug: Fenofibrate

WMER Niacin Monotherapy

ACTIVE COMPARATOR

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive a night-time 500 mg daily single dose of Wax Matrix Extended Release Niacin (WMER Niacin, ENDUR-ACIN®500mg, Endurance Products Company, Oregon USA) for one week, titrated up to 1000 mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Other: Therapeutic Lifestyle Changes; Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)

Combination Therapy

ACTIVE COMPARATOR

Non-responders to four-week therapeutic lifestyle changes run-in period, will start to receive an after lunch 200mg daily single dose of fenofibrate for eight weeks, in combination with a night-time 500 mg daily single dose of WMER Niacin for one week, titrated up to 1000mg by adding a daily morning-time ENDUR-ACIN®500mg tablet for the next seven weeks.

Other: Therapeutic Lifestyle Changes; Drug: Fenofibrate; Dietary Supplement: Wax Matrix Extended Release Niacin (WMER Niacin)

Interventions

Therapeutic Lifestyle Changes OTHER

Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.

Combination Therapy; Fenofibrate Monotherapy; Placebo; WMER Niacin Monotherapy

Placebo OTHER

Placebo

Fenofibrate DRUG

Also known as: Lipanthyl

Combination Therapy; Fenofibrate Monotherapy

Wax Matrix Extended Release Niacin (WMER Niacin) DIETARY_SUPPLEMENT

Also known as: ENDUR-ACIN®

Combination Therapy; WMER Niacin Monotherapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI≥30 kg/m2.
• Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.

You may not qualify if:

• The use of any antilipidemic medication.
• Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).
• Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).
• Clinical or laboratory findings suggestive for thyroid dysfunction.
• Established diagnosis of Diabetes Mellitus.
• History of gout, hyperuricemia, or on hypouricemic agents.
• Active peptic ulcer.
• Pregnancy, or nursing mothers.
• Alcohol or tobacco consumption.

Sponsors & Collaborators

• Lewai Sharki Abdulaziz, MSc PhD: lead
• Al-Kindy College of Medicine: collaborator

Study Sites (2)

Al Kindy College of Medicine, University of Baghdad

Baghdad, 10045, Iraq

Location

Lewai S Abdulaziz

Baghdad, 10045, Iraq

Location

MeSH Terms

Conditions

Obesity

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Lewai Sharki Abdulaziz
• Organization: Al-Kindy College of Medicine, ////university of Baghdad

lewaisharki@kmc.uobaghdad.edu.iq

750 659 0024

Study Officials

• Lewai S Abdulaziz, MSc PhD

  Al-Kindy college of Medicine, University of Baghdad

  STUDY CHAIR

• May S Al-Sabbagh, MSc

  College of Pharmacy, University of Baghdad

  STUDY CHAIR

• Marwah S Attar, MSc

  College of Pharmacy, University of Baghdad

  STUDY DIRECTOR

• Faris A Khazaal, FRCP

  Al-Kindy college of Medicine, University of Baghdad

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 6, 2018
• Study Start: October 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: October 30, 2015
• Last Updated: January 24, 2024
• Results First Posted: October 12, 2018

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 24 months following article publication
• Access Criteria: Anyone who wishes to access the data, to achieve aims in the approved proposal or for meta-analysis. The data will be available in our college's data warehouse up to 24 months following article publication.

Locations

IR (2)