ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) (NCT06342947) | Clinical Trial Compass
CompletedPhase 2
ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)
United States102 participantsStarted 2024-04-01
Plain-language summary
This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Male or female, 18 to 75 years of age
* Body mass index (BMI) ≥ 25 kg/m2
* Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following:
* Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least a score of 1 in each of the NAS components; OR
* Having ≥2 metabolic syndrome criteria and a screening FibroScan liver stiffness measurement between 7 - 20 kPa
* Screening FibroScan with CAP score of \>300 dB/m
* Screening MRI-PDFF with ≥10% liver fat content
Key Exclusion Criteria:
* History or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)
* History or current evidence of cirrhosis
* History of liver transplantation or known planned liver transplantation
* History or current evidence of a pituitary disorder or hyperthyroidism
* Untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening.
* TSH, free T4, or Total T3 \>1.1 x ULN or \<0.9 x LLN
* Clinically concerning abnormal ECG or cardiac history
* HbA1c ≥9.5%
* Platelet count ≤135,000/mm3
* ALT or AST \>5 x ULN
* INR \>1.3
* Albumin \<3.5 g/dL
* eGFR \<45 mL/min/1.73 m2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent relative change from baseline in liver fat content