The Cotter Research Group have actively enrolling AASLD- and NIH-funded clinical studies, as well as a sponsor-initiated clinical study. See below to find out more on each study.
The Dallas Dionysus Study
A prospective observational study assessing the interplay between various clinicodemographic (including alcohol use patterns and metabolic syndrome), biologic (including genetics) and social factors in the prognosis of alcohol-associated liver disease (ALD) and metALD. Participants complete surveys, liver stiffness measurement (via vibration-controlled transient elastography (i.e. Fibroscan)) and provide blood samples at baseline, and are followed prospectively with protocolized visits every 6 months.
The inclusion/exclusion criteria include the following
- ALT >33 (males), ALT >25 (females)
- No other liver disease present (e.g. Hepatitis B or C) that may explain the clinical findings
- imaging with steatosis (CT, MR, US, or VCTE)
- Alcohol: >140g/week (10 SDs) in females or >210g/week (15 SDs) in males”
OR - Diagnosis of met-ALD or ALD cirrhosis”
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
This is a phase 2a, randomized, double-blind, placebo-controlled, dose-escalation, proof-of-concept study of INT-787 in patients with severe alcohol-associated hepatitis (sAH).
The inclusion criteria include the following
- Adults between 18 and 65 years with a clinical diagnosis of severe alcohol-associated hepatitis (sAH) with original MELD score between 18 and 25, and Maddrey’s discriminant function between 32 and 70.
- Study participants should not have:
- received more than 2 doses of systemic corticosteroids
- been inpatient at a referral hospital more than 7 days prior to transfer
- a positive urine drug screen unless cannabis or the presence of an explanatory prescription
- have liver cancer
- be listed for liver transplant
- have traditional contraindications to sAH medical treatment (e.g. uncontrolled infection or GI bleeding, kidney injury (creatinine >1.5)
- severe symptomatic co-morbidities (such as pancreatitis, cholecystitis, cardiac failure, myocardial infarctions, severe pulmonary disease); or HIV