OPK-88006 for Presumed MASH
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called OPK-88006, an experimental therapy for individuals with presumed MASH, a liver condition linked to metabolic issues. The trial aims to assess the treatment's safety and its effects on the body compared to a placebo, which contains no active ingredient. The trial seeks participants with metabolic risk factors and specific liver test results, who have maintained a stable weight and are willing to follow trial guidelines. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Is there any evidence suggesting that OPK-88006 is likely to be safe for humans?
Research has shown that treatments like OPK-88006, a GLP-1 receptor agonist, can aid individuals with MASH, a liver disease. Patients typically tolerate these treatments well. In studies, most participants did not experience serious side effects, and any side effects were generally mild, such as nausea or headaches.
This trial includes both early and later testing stages. Early-stage trials assess the drug's safety and how the body processes it. If OPK-88006 is in these stages, it is still undergoing careful safety testing. However, the usual tolerance of similar treatments provides some confidence in its safety.12345Why do researchers think this study treatment might be promising for MASH?
Researchers are excited about OPK-88006 because it offers a novel approach to tackling Metabolic Associated Steatohepatitis (MASH). Unlike traditional treatments that primarily focus on lifestyle changes and general liver health, OPK-88006 targets the underlying metabolic processes contributing to the disease. This treatment leverages a unique mechanism of action that could potentially alter the progression of MASH more effectively. Additionally, the drug is being tested in various dosing regimens, which might reveal optimal strategies for managing the condition.
What evidence suggests that OPK-88006 might be an effective treatment for MASH?
Research has shown that OPK-88006 could help treat MASH, a serious liver condition, by targeting GLP-1 and glucagon receptors. Studies have found that focusing on these receptors can improve liver health by reducing fat and inflammation. In one study with mice, OPK-88006 protected the liver more effectively than other similar drugs. Additionally, drugs like OPK-88006 that affect GLP-1 receptors have successfully improved liver conditions and lowered health risks for people with MASH. These findings suggest that OPK-88006 could be a strong option for enhancing liver health in MASH patients. Participants in this trial will receive OPK-88006 in different cohorts to evaluate its effectiveness and safety.16789
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who are in good general health, have a BMI between 27 and 35, and can follow study rules. Some participants will be healthy volunteers; others may have presumed MASH (a liver condition).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
SAD Phase
Single Ascending Dose (SAD) phase in healthy participants to evaluate safety and pharmacokinetics
MAD Phase
Multiple Ascending Dose (MAD) phase in participants with presumed MASH to evaluate safety, pharmacokinetics, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OPK-88006
Trial Overview
The study tests OPK-88006 compared to placebo. It has two parts: first, single doses in healthy people; then, multiple doses in people with presumed MASH. The main goals are to check safety and how the body processes the drug.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
OPKO Health, Inc.
Lead Sponsor
Citations
Efficacy and safety of GLP-1 receptor agonists in MASH ... - PMC
GLP-1 RAs improve MASH and MASH-associated hepatic fibrosis while also improving cardiometabolic risk factors in patients with MASH.
Superior Hepatoprotective Effects of OPK-88006, a Novel ...
The present study aimed to compare the therapeutic profile of OPK-88006, semaglutide (GLP1R monoagonist) and survodutide (dual GLP1R-GCGR agonist) in the ...
3.
boehringer-ingelheim.com
boehringer-ingelheim.com/human-health/crm-health/metabolic-health/survodutide-top-line-results-mash-fibrosissurvodutide top-line results MASH fibrosis
Survodutide Phase II trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant ...
Efficacy and safety of anti-obesity drugs in metabolic ...
Efficacy and safety of anti-obesity drugs in metabolic dysfunction-associated steatotic liver disease: An updated review.
5.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/glp-1-receptor-agonist-shows-significant-improvements-in-treatment-of-metabolic-dysfunction-associated-steatohepatitis-in-phase-ii-trialGLP-1 Receptor Agonist Shows Significant Improvements ...
Survodutide produced a statistically significant improvement in metabolic dysfunction-associated steatohepatitis among 83% of those administered ...
6.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/OPK/pressreleases/3595607/opko-health-launches-early-mash-trial-that-could-shape-its-next-growth-chapter/Opko Health Launches Early MASH Trial That Could ...
The goal is to see if OPK-88006 can safely change disease related signals in people with presumed MASH, while building early evidence that could ...
Metabolic Dysfunction-Associated Steatohepatitis Trials
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants. A Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic ...
8.
liverfoundation.org
liverfoundation.org/liver-diseases/fatty-liver-disease/nonalcoholic-steatohepatitis-nash/mash-causes-and-risk-factors/MASH Causes & Risk Factors
Discover the key risk factors for MASLD and MASH, including obesity, diabetes, and more. Learn about the prevalence in children and adults.
MASLD and MASH
MASH is a more severe and aggressive form of MASLD and can cause swelling, inflammation, and liver damage — or may stay silent and cause no symptoms at all.
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