Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins

NCT03198793 | Completed Phase 2

• 1 other identifier: QGC001-2QG3
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Essential hypertension (HTN) is a disease that affects approximately 1 billion individuals worldwide. Despite the availability of effective and safe anti-hypertensive drugs, 65% of subjects diagnosed with HTN do not have their blood pressure (BP) controlled (\<140/90 mmHg). The overall incidence of resistant HTN, (defined as requiring 3 or more anti-hypertensive drugs, including a diuretic, to control BP) is estimated to be 15% of the hypertensive population. Consequently, there is a pressing unmet medical need to develop new classes of anti-hypertensive drugs that act on alternative pathways and further control BP and the associated cardiovascular risks in subjects. The prevalence of HTN in African Americans in the United States is among the highest in the world, and HTN is more common in African Americans than in Caucasians. One of the risk factors for HTN is sodium sensitivity. There is a higher association of HTN with sodium sensitivity in African American subjects and other racial/ethnic groups who are overweight/obese. Effective agents to treat HTN in this high-risk population are clearly needed. This study will be conducted in a hypertensive, overweight subject population of multiple ethnic origins in which QGC001 is likely, based on its mode of action, to demonstrate a significant anti-hypertensive effect.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in office systolic blood pressure from baseline to Week 8 (Day 56 Visit)

  Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).

  8 weeks

Secondary Outcomes (5)

• Change in office diastolic blood pressure from baseline to Week 8 (Day 56 Visit)

  8 weeks

• Change in office systolic blood pressure and diastolic blood pressure from baseline to Week 4 (Day 28 Visit)

  4 weeks

• Change in mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, and mean office blood pressure from baseline to Week 8 (Day 56 Visit)

  8 weeks

• Percentage of responders (defined as subjects with normalized office blood pressure, ie, less than or equal to 140-90 mmHg at Week 8 - Day 56 Visit)

  8 weeks

• Predictive factors for responders at Week 8 (Day 56 Visit)

  8 weeks

Study Arms (1)

QGC001

EXPERIMENTAL

Capsules of QGC001 250 mg

Drug: QGC001

Interventions

QGC001 DRUG

Twice daily (BID) administration of oral (PO) QGC001 (250 mg BID, 500 mg BID, and 500 mg BID + hydrochlorothiazide (HCTZ) 25 mg once daily \[QD\]) over 8 weeks.

QGC001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide signed written informed consent;
• Men and women greater than or equal to 18 years of age at Screening;
• Diagnosis of primary (essential) hypertension (HTN) for at least 3 months prior to Screening and have an office SBP:
• Between 145 mmHg and 170 mmHg at Screening and are treatment-naïve; or
• Between 130 mmHg and 150 mmHg at Screening and are treated with less than or equal to 2 anti hypertensive medications. Anti-hypertensive medications must be stable for greater than or equal to 8 weeks prior to Screening;
• Body mass index between 25 kg/m2 and 45 kg/m2 with the ability to fit the ambulatory blood pressure monitoring (ABPM) cuff per the manufacturer;
• Subject must have a successful ABPM measurement prior to receiving the study drug.
• Women of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post-dose.

You may not qualify if:

• Known or suspected secondary HTN (eg, renal artery stenosis, pheochromocytoma, Cushing's disease);
• Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy;
• History of spontaneous or drug-induced angioedema;
• Clinically significant valvular heart disease or severe aortic stenosis;
• Subjects with symptomatic heart failure (New York Heart Association Class II to Class IV);
• History of acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Screening;
• Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures, that induce chronic malabsorption, within 2 years of Screening;
• Treatment with anti-obesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight;
• Female who is breast feeding, pregnant, or planning to become pregnant during the study period;
• Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years;
• Subject with an upper arm circumference that exceeds the upper circumference level (48.3 cm) of the cuff size of either the ABPM and/or office BP (OBP) measurement device used in the study;
• Night shift workers who routinely sleep during the daytime and/or whose work hours include midnight;
• History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic anemia, thalassemia, sickle cell anemia);
• Subjects with type 1 diabetes mellitus;
• Subjects with type 2 diabetes mellitus who:

Sponsors & Collaborators

• Quantum Genomics SA: lead

Study Sites (1)

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Related Publications (3)

• Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.

  PMID: 33027067 DERIVED

• Ferdinand KC, Harrison D, Johnson A. The NEW-HOPE study and emerging therapies for difficult-to-control and resistant hypertension. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):64-73. doi: 10.1016/j.pcad.2019.12.008. Epub 2020 Jan 8.

  PMID: 31923435 DERIVED

• Ferdinand KC, Balavoine F, Besse B, Black HR, Desbrandes S, Dittrich HC, Nesbitt SD. Efficacy and Safety of Firibastat, A First-in-Class Brain Aminopeptidase A Inhibitor, in Hypertensive Overweight Patients of Multiple Ethnic Origins. Circulation. 2019 Jul 9;140(2):138-146. doi: 10.1161/CIRCULATIONAHA.119.040070. Epub 2019 Apr 24.

  PMID: 31014072 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Keith C. Ferdinand, MD FACC

  Tulane University SOM, New Orleans, LA 70112

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 26, 2017
• Study Start: October 13, 2017
• Primary Completion: October 16, 2018
• Study Completion: November 12, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)