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Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers

A 61-day Randomized, Double Blind, Placebo-controlled Trial to Assess the Safety and Efficacy of Three Doses of HU6 in Subjects With Elevated Liver Fat and High Body Mass Index (28 to 45 kg/m2)

NCT04874233•Rivus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Detailed Description

This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat. Subjects will be screened over a 45 day period to determine their eligibility based on specific history, physical, laboratory and imaging evaluations as per the Schedule of Assessments. Due to scheduling of the procedures, multiple visits will likely be necessary to complete the screening process. However, if all screening assessments and procedures, including the MRI, can be completed within 30 days of the first dose, then a single screening visit is permissible.

Eligibility

Age

28 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Adult male or females, 28 to 65 years of age (inclusive) at the time of informed consent with BMI between 28.0 and 45.0 kg/m2 (inclusive).
•1. Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative urine pregnancy test at Screening and agree to continue using an effective method of contraception for at least 4 weeks or barrier method for 2 weeks prior to first study drug administration until 30 days after the last dose of study drug (Section 8.3.2).
•2. Female subjects of childbearing potential must not donate ova during the study and for at least 30 days after the last dose of study drug.
•3. Female subjects of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, oophorectomy) or postmenopausal (no menses for \>1 year with follicle stimulating hormone (FSH) \>40 U/L at Screening).
•4. Male subjects who have not had a vasectomy and/or subjects who have had a vasectomy but have not had 2 post surgery negative tests for sperm must agree to use an acceptable method of contraception from time of first dose of study drug until 30 days after the last dose of the study drug, and to not donate sperm during the study and for at least 30 days after the last dose of study drug.
•2\. Inclusion as per investigator assessment of general medical status and as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations.
•
•1. Subjects must be on stable doses of medications for underlying obesity-related conditions for at least 2 months prior to screening.
•2. Subjects with diabetes may be treated with metformin, DPP-4 inhibitors, or sulfonylureas, but must be on stable doses for at least 2 months prior to screening.
•3. At Screening, certain laboratory values may be outside the reference range if commensurate with the underlying obesity or associated metabolic dysfunction in the eligible subject (for example, dyslipidemia and hyperglycemia), unless these abnormalities suggest an underlying condition which may impact subject safety in the trial or interfere with the evaluation of HU6 or affect interpretation of the study results.
+5 more criteria

Exclusion Criteria

•Subjects will be excluded from the study if any of the following criteria are met:
•1. Insulin-controlled diabetes.
•2. Pregnant or breastfeeding or plans to become pregnant.
•3. Intolerance to Magnetic Resonance Imaging (MRI) or with conditions contraindicated for MRI procedures including but not limited to inability to fit into MRI scanner or surgical clips/metallic implants/shrapnel. Subjects must not be claustrophobic, have a history of claustrophobia, or intolerance of closed or small spaces.
•4. Weight gain or loss \>5% in 3 months prior to study or \>10% in 6 months prior to screening.
•5. History of lap banding, intragastric balloon, duodenal-jejunal sleeve, or bariatric surgery within 5 years of screening, plans for bariatric surgery prior to conclusion of study participation, or plans to lose weight during this study either through a special diet, exercise program or both.
•6. History of malignant hyperthermia.
•7. History of chronic serious recurrent skin rashes of unknown cause.
•8. History of or current clinically significant cardiovascular disease including but not limited to transient ischemic attack, stroke, cardiac arrhythmias, syncope, unstable angina, myocardial infarction in the 6 months prior to screening, congestive heart failure, or uncontrolled hypertension. (Uncontrolled hypertension is defined as a systolic blood pressure ≥160 mmHg or a diastolic blood pressure ≥100 mmHg based on an average of three resting determinations in the sitting position with an appropriately sized cuff).
•9. Resting heart rate \<45 or \>110 bpm.
+48 more criteria

Locations (1)

Prism Clinical Research

Minneapolis, Minnesota, United States

Key Dates

Start Date

April 19, 2021

Primary Completion Date

November 30, 2021

Completion Date

December 15, 2021

Last Updated

March 1, 2024

Enrollment

ACTUAL participants

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

HU6

DRUG

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers

Inclusion Criteria

Exclusion Criteria

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