A Randomized, Open-label, Phase 1b Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Signals of DUR-928 in Patients with Non-Alcoholic Steatohepatitis (NASH)

About this Study

Nonalcoholic fatty liver disease (NAFLD) is a condition in which excess fat is deposited in the liver. Two types of NAFLD are simple fatty liver (NAFL – nonalcoholic fatty liver), and nonalcoholic steatohepatitis (NASH). NASH is a form of NAFLD in which one will have inflammation of the liver and liver cell damage, in addition to and related to excess fat within the liver. It is the hope that DUR-928 can treat participants with NASH by reducing liver inflammation and liver cell damage, and so prevent development of scar tissue within the liver.

Sponsor Protocol ID:	C928-012
IRB Number:	2019-0154
Study Status: Study Status Actively Enrolling: The study is currently recruiting participants. Closed for Enrollment: The study is not currently recruiting participants.	Closed for Enrollment
Study Type: Study Type Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.	Interventional
Study Phase: Study Phase Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.	Phase 1
Online Start Date: Online Start Date The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.	August 22, 2019

Eligibility Criteria

Minimum Age Age Requirement Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.	18 years old
Maximum Age Age Requirement Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.	100 years old
Biological Sex Biological Sex Requirement Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.	Both Male and Female
Cancer Related? Cancer Related Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.	No
Pediatric Related? Pediatric Related Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.	No
Accepts Healthy Volunteers? Accepts Healthy Volunteers Indicates whether people who do not have the condition/disease being studied can participate in the clinical study. Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.	No

Inclusion Criteria1. Subjects must be able and willing to provide written informed consent to participate in the study

2. Males or females subjects 18 years or older, at the time of signing informed consent

3. Female subjects are eligible for the study if they meet the following criteria: o Are not pregnant or nursing o Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the study duration. Acceptable methods that may be used are abstinence, birth control pills (“The Pill”) or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner

4. Male participants must agree to consistently and correctly use a condom in combination with one of the above methods of birth control from enrolment to 30 days after the last dose of study medication

5. Participants must be able to comply with dosing and able to complete the study schedule of assessments

Exclusion Criteria1. Refusal or inability to provide informed consent to participate in the study

2. Average weekly alcohol ingestion ≥21 units in male subjects and ≥14 units in female subjects for 2 years prior to enrollment, where a “unit” of alcohol is equivalent to a 12 ounce beer, 4 ounce glass of wine, or 1 ounce shot of hard liquor

3. Presence of chronic liver disease from other cause, including but not limited to: Wilson(‘s) disease, hemochromatosis, active viral hepatitis, autoimmune, cholestatic, malignant, drug-induced

4. History of HIV infection

5. Concurrent disease:

o Uncontrolled hypertension

o Inflammatory bowel disease (IBD)

o Uncontrolled cardiovascular disease

o Stroke within 24 weeks of screening

o Type I diabetes mellitus

o Acute or chronic active systemic infection o History of malignancy within 3 years prior to Screening with the following exceptions:

o Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or on the interpretation of the study data

6. Concurrent medication

7. History of bariatric surgery

8. Inadequate venous access

9. ≥10% bodyweight change in the past 12 months

10. History of substance abuse in the medical judgment of the investigator

11. Any situation that in the Investigator’s opinion, may interfere with optimal study participation such as domicile too distant from study site, potential non-compliance during the study or inability to cooperate because of a language problem or poor mental status

Categories Click category to view its trials.

Liver Diseases

Preventive Medicine

Participating Locations

Belhaven Building - UMMC

University Hospital - UMMC

Contact Information