HypertensionPhase 2NEW-HOPENCT03198793
Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins
A Phase 2 study testing QGC001 in people with Hypertension, run by Quantum Genomics SA at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- QGC001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2017to 12 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- SBP between 145 mmHg and 170 mmHg, inclusive, and DBP less than or equal to 105 mmHg at the Inclusion Visit after 2-week Run In Period;
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- 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.
- Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Day 0).
Who cannot join
- Known or suspected secondary HTN (eg, renal artery stenosis, pheochromocytoma, Cushing's disease);
- Office SBP greater than or equal to 171 mmHg and/or office diastolic blood pressure (DBP) greater than or equal to 105 mmHg at the Inclusion Visit (Day 0) and confirmed by a second measurement (not on the same day), preferably within 1 day;
- 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);
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- 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;
- Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase >3 x upper limit of normal (ULN) or a total bilirubin greater than or equal to 2 x ULN (unless secondary to Gilbert's syndrome) at Screening or the Inclusion Visit (Day 0);
- Estimated glomerular filtration rate <45mL/min/1.73m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration formula at Screening or the Inclusion Visit (Day 0);
- 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:
- Are poorly controlled, defined as hemoglobin A1c >8% at Screening; or
- Are taking short-acting insulin or sodium-glucose co transporter 2 inhibitors. Use of a stable dose (greater than or equal to 12 weeks prior to Screening) of medications listed in Appendix C is permitted;
- Routine or anticipated treatment with all systemic corticosteroids. Use of topical, inhaled, or nasal corticosteroids is permitted;
- Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable greater than or equal to 4 weeks prior to Screening, or subjects with the following thyroid-stimulating hormone (TSH) levels at Screening:
- For subjects on replacement therapy: TSH 0.75 to 1.5 x ULN; or
- For subjects not on replacement therapy: TSH >1.5 x ULN;
- History of alcohol or drug abuse within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or study drug intake in the Investigator's opinion;
- Participation in another clinical study involving an investigational drug within 30 days prior to Screening, or plans to participate in another clinical study within 30 days of discontinuation of study drug;
- Any condition, in the opinion of the Investigator, that would interfere with study participation, may pose a risk to the subject, or would make study participation not in the best interest of the subject;
- Subjects with a life expectancy of less than 1 year per Investigator's discretion; or
- Any subject who, in the opinion of the Investigator, will not be able to follow the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Progressive Medical Research
Port Orange, Florida, 32127
About this study
Official title: A Phase 2, Open-Label, Dose-Titrating Safety and Efficacy Study of QGC001 Administered Orally, Twice Daily, Over 8 Weeks in Hypertensive Overweight Subjects of Multiple Ethnic and Racial Groups in the United States
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.
Read more
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.
Read the detailed description
QGC001 is a prodrug of the specific and selective APA inhibitor, EC33, and is the prototype of a new class of centrally-acting anti-hypertensive agents called brain APA inhibitors. Inhibition of brain APA, which converts Ang II into Ang III, has emerged as a novel anti hypertensive treatment, as demonstrated in several experimental animal models. QGC001's anti-hypertensive effect is in part due to: 1) a decrease in arginine vasopressin release in the blood circulation, increasing diuresis, which reduces the size of body fluid compartment; and 2) a reduction in the sympathetic tone, leading to subsequent decreases in vascular resistances.
This study is an open-label, dose-titrating safety and efficacy study of QGC001 administered PO, BID, over 8 weeks in hypertensive overweight subjects of multiple ethnic and racial groups in the United States.
The primary objective of this study is to assess the effects of 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]) on blood pressure (BP) over 8 weeks in hypertensive overweight/obese subjects of multiple races/ethnicities.
- Conditions
- Hypertension
- Being tested
- QGC001
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGC001Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| QGC001 | Experimental | Capsules of QGC001 250 mg Receives: Drug: QGC001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (5)
Change in office diastolic 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).
Measured: 8 weeks
Change in office systolic blood pressure and diastolic blood pressure from baseline to Week 4 (Day 28 Visit)
Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).
Measured: 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)
Ambulatory blood pressure monitoring will be performed at Day 0 and Day 56.
Measured: 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)
Frequency and percentage of subjects who reach the level by the Week 8 (Day 56 Visit).
Measured: 8 weeks
Predictive factors for responders at Week 8 (Day 56 Visit)
Identification of potential factors for responders, including baseline systolic blood pressure and diastolic blood pressure, gender, age, BMI, and others.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start13 Oct 2017
- Primary completion16 Oct 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith C. Ferdinand, MD FACC, Study chair, Tulane University SOM, New Orleans, LA 70112
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198793
- Sponsor's protocol ID
- QGC001-2QG3
- Acronym
- NEW-HOPE
- Status last verified
- Dec 2018
- First submitted
- 16 Jun 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33027067Ferdinand 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.
PubMed 31923435Ferdinand 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.
PubMed 31014072
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Dose-Titrating Safety and Efficacy Study of QGC001 Administered Orally, Twice Daily, Over 8 Weeks in Hypertensive Overweight Subjects of Multiple Ethnic and Racial Groups in the United States
- ClinicalTrials.gov ID
- NCT03198793
- Acronym / sponsor ID
- NEW-HOPE / QGC001-2QG3
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
QGC001 is a prodrug of the specific and selective APA inhibitor, EC33, and is the prototype of a new class of centrally-acting anti-hypertensive agents called brain APA inhibitors. Inhibition of brain APA, which converts Ang II into Ang III, has emerged as a novel anti hypertensive treatment, as demonstrated in several experimental animal models. QGC001's anti-hypertensive effect is in part due to: 1) a decrease in arginine vasopressin release in the blood circulation, increasing diuresis, which reduces the size of body fluid compartment; and 2) a reduction in the sympathetic tone, leading to subsequent decreases in vascular resistances.
This study is an open-label, dose-titrating safety and efficacy study of QGC001 administered PO, BID, over 8 weeks in hypertensive overweight subjects of multiple ethnic and racial groups in the United States.
The primary objective of this study is to assess the effects of 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]) on blood pressure (BP) over 8 weeks in hypertensive overweight/obese subjects of multiple races/ethnicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QGC001 | Experimental | Drug: QGC001Capsules of QGC001 250 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- SBP between 145 mmHg and 170 mmHg, inclusive, and DBP less than or equal to 105 mmHg at the Inclusion Visit after 2-week Run In Period;
- 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;
Key exclusion criteria (29 listed)
- Known or suspected secondary HTN (eg, renal artery stenosis, pheochromocytoma, Cushing's disease);
- Office SBP greater than or equal to 171 mmHg and/or office diastolic blood pressure (DBP) greater than or equal to 105 mmHg at the Inclusion Visit (Day 0) and confirmed by a second measurement (not on the same day), preferably within 1 day;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QGC001Twice 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. | Drug | QGC001 |
Primary outcome
Change in office systolic blood pressure from baseline to Week 8 (Day 56 Visit)
Time frame: 8 weeks
Office blood pressure will be taken at Day 0, Visit 3, Visit 4, Visit 4.1, and Visit 5 (Day 56).
5 secondary outcomes
Change in office diastolic blood pressure from baseline to Week 8 (Day 56 Visit)
Time frame: 8 weeks
Change in office systolic blood pressure and diastolic blood pressure from baseline to Week 4 (Day 28 Visit)
Time frame: 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)
Time frame: 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)
Time frame: 8 weeks
Predictive factors for responders at Week 8 (Day 56 Visit)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 33027067Khosla 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.
- Derived from this study: PubMed 31923435Ferdinand 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.
- Derived from this study: PubMed 31014072Ferdinand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith C. Ferdinand, MD FACC study chair
Tulane University SOM, New Orleans, LA 70112
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QGC001 in people with Hypertension, run by Quantum Genomics SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic blood pressure from baseline to Week 8 (Day 56 Visit) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198793, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.