Dyslipidemia of Obesity Intervention in Teens

NCT02956590 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: PHN DO IT!
• Study Type: interventional
• Target: 122
• Locations: 2 countries
• Sites: 16

Brief Summary

This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.

Conditions

Dyslipidemia; Obesity

Keywords

dyslipidemia; obesity; pitavastatin; lipids

Outcome Measures

Primary Outcomes (1)

• the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)

  Pulse wave velocity (PWV)

  2 years

Secondary Outcomes (12)

• the effect of pitavastatin versus placebo on vascular measures in obese adolescents with combined dyslipidemia of obesity (CDO)

  2 years

• the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity

  2 years

• the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP)

  2 years

• the effect of pitavastatin versus placebo on lipid measures

  2 years

• the effect of pitavastatin versus placebo on Nuclear magnetic resonance (NMR) Spectroscopy Lipoprotein Particle Assessment

  2 years

Study Arms (2)

Pitavastatin

ACTIVE COMPARATOR

Study Drug

Drug: Pitavastatin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pitavastatin DRUG

Statin

Also known as: Livalo

Pitavastatin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
• BMI ≥85th percentile (using Centers for Disease Control (CDC) BMI charts)
• Fasting lipid profile x2 each with all of the following:
• LDL-C \<160 mg/dL and ≥90 mg/dL, and
• TG (triglycerides) \<500 mg/dL, and
• TG/HDL-C ratio ≥2.5 or HDL-C \<45 mg/dL for boys or HDL-C \<50 mg/dL for girls, and
• non-HDL-C ≥120 mg/dL
• Participant consent, or parental/guardian consent and participant assent

You may not qualify if:

• Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
• Known allergy or hypersensitivity to statin
• Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
• Female who is pregnant, plans to become pregnant or is sexually active without contraception
• Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants \<13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
• Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
• Use of insulin sensitizing therapy
• Known renal insufficiency (known chronic renal disease, estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m2 at screening)
• Uncontrolled thyroid disease (TSH at screening \>1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
• Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
• Syndromic patients or patients with neurocognitive delay precluding adherence with study drug
• Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or suggested by alanine aminotransferase (ALT) ≥ 40 U/L, or severe NAFLD indicated by ALT ≥ 200 U/L
• Unexplained persistent elevated creatine kinase (CK) level \>3x upper limit of normal
• Plans to leave the geographic area before completion of the anticipated 2 years of trial participation
• Any unstable medical or emotional condition or chronic disease that would preclude following the protocol or impact valid vascular measurement

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (16)

Nemours/Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02114, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital, University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5g 1X8, Canada

Location

Related Publications (1)

• de Ferranti SD, Teng JE, Arslanian SA, Atz AM, Brothers JA, Cartoski MJ, Freemon DR, Magge SN, Mahle WT, Mietus-Snyder M, Peterson A, Raghuveer G, Russell MW, Shah AS, Sponseller CA, Stylianou M, Trachtenberg FL, Urbina EM, Ware AL, Zachariah J, Zadokar VV, McCrindle BW; Pediatric Heart Network Investigators. A multicenter trial to test pitavastatin calcium in youth with combined dyslipidemia of obesity: Design, implementation, challenges, and responses. Am Heart J. 2025 Dec 15;294:107327. doi: 10.1016/j.ahj.2025.107327. Online ahead of print.

  PMID: 41407061 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Obesity

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 7, 2016
• Study Start: May 1, 2018
• Primary Completion: April 21, 2023
• Study Completion: June 30, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (15); CA (1)