30 Participants NeededMy employer runs this trial

OPK-88006 for Presumed MASH

OH
Overseen ByOPKO Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I have metabolic risk factors and liver test results suggesting MASH.
Part A: Good general health per investigator assessment
Part B: BMI ≥27 and ≤40 kg/m² with stable weight
See 5 more

Exclusion Criteria

Part B: Clinically significant abnormal labs such as elevated liver enzymes, HbA1c ≥9.5%, or abnormal ECG findings
I have had pancreatitis, cancer in the last 5 years, or problems with substance misuse.
I have recently used GLP-1 agonists or anti-obesity medications.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SAD Phase

Single Ascending Dose (SAD) phase in healthy participants to evaluate safety and pharmacokinetics

Up to 2 weeks
Multiple visits for dose administration and monitoring

MAD Phase

Multiple Ascending Dose (MAD) phase in participants with presumed MASH to evaluate safety, pharmacokinetics, and pharmacodynamics

Up to 20 weeks
Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: SAD - Cohort 3 OPK-88006Experimental Treatment1 Intervention
Group II: SAD - Cohort 2 OPK-88006Experimental Treatment1 Intervention
Group III: SAD - Cohort 1 OPK-88006Experimental Treatment1 Intervention
Group IV: MAD - OPK-88006/PlaceboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

OPKO Health, Inc.

Lead Sponsor

Trials
48
Recruited
5,100+

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 ...

survodutide 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.

GLP-1 Receptor Agonist Shows Significant Improvements ...

Survodutide produced a statistically significant improvement in metabolic dysfunction-associated steatohepatitis among 83% of those administered ...

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 ...

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.