Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
Public ClinicalTrials.gov record NCT05284617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Exploratory Phase 2A, Double-blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety, Tolerability, PD, and PK of HU6 for the Treatment of Subjects With Obese Heart Failure With Preserved Ejection Fraction (HFpEF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within \~14 days of the last dose.
Study identification
- NCT ID
- NCT05284617
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 67 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 30, 2022 (Actual)
- Primary completion
- May 24, 2024 (Actual)
- Completion
- May 30, 2024 (Actual)
- Last update posted
- Aug 26, 2024
2022 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Heart Institute | Beverly Hills | California | 90211 | — |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Torrance | California | 90502 | — |
| New Generation of Medical Research | Hialeah | Florida | 33002 | — |
| Broward Research Center | Pembroke Pines | Florida | 33029 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Saint Luke's Mid America Heart Institute | Kansas City | Missouri | 64111 | — |
| Weill Cornell Medicine | New York | New York | 10012 | — |
| Wake Forest | Winston-Salem | North Carolina | 27105 | — |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05284617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05284617 live on ClinicalTrials.gov.