A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH
NCT ID: NCT06410924
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
67 participants
INTERVENTIONAL
2024-06-13
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DD01
Study Drug
DD01
Dual GLP-1 and glucagon receptor agonist
Placebo
Matching Placebo
Placebo
Placebo matching DD01
Interventions
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DD01
Dual GLP-1 and glucagon receptor agonist
Placebo
Placebo matching DD01
Eligibility Criteria
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Inclusion Criteria
* With MASLD or confirmed diagnosis of MASH based on MRI PDFF ≥10% AND 1 of the following:
1. Biopsy proven MASH obtained during Screening which confirms the presence of MASH characterized by a NAS ≥4 with at least 1 in each component (steatosis, ballooning, and lobular inflammation) and fibrosis stage F1 to F3. A historical biopsy obtained within 6 months may be acceptable OR
2. Meets at least 2 additional metabolic syndrome factors
* Participants with a BMI ≥25 kg/m2, with stable body weight by history for 3 months
* Participants must have a waist circumference ≥35 inches (females), or ≥40 inches (males), and must have a waist circumference ≤57 inches (both males and females)
* Female participants must be non-pregnant, non-lactating or post-menopausal
Exclusion Criteria
* Liver cirrhosis (fibrosis stage F4), any prior history of hepatic decompensation, including low platelet counts, esophageal varices, ascites, hepatic encephalopathy, splenomegaly, any hospitalization for treatment of chronic liver disease, or a Model for End Stage Liver Disease score of ≥12
* Recent (within 3 months of Screening) use of therapies associated with development of MASLD/MASH (eg, systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines)
* Previous surgical treatment for obesity as well as clinically significant GI disorders
* Type 1 diabetes mellitus, or T2DM on insulin and/or GLP-1 receptor agonist therapy, dipeptidyl peptidase-4 inhibitors, or other therapies
* Uncontrolled hypertension or uncontrolled dyslipidemia
* Participated in an investigational study within 30 days prior to dosing or who have participated in another MASLD/MASH interventional study within 60 days prior to Screening
* With a history or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis, symptomatic cholelithiasis and/or choledocholithiasis, or alcohol abuse
* With a history of any major surgery within 3 months prior to Screening
* With heart failure (New York Heart Association Class III or IV) or any cardiovascular event or evidence of active cardiovascular disease
* With a presence of clinically significant 12-lead ECG findings at Screening, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Screening
* With personal or family history of medullary thyroid carcinoma (MTC)
* With a history of renal disease
* With a history of alcohol or illicit drug abuse
* A positive test for hepatitis B surface antigen, hepatitis C RNA, or HIV type 1 or type 2 antibody
* A clinically significant physical examination, ECG, or laboratory finding, as judged by the Investigator, may interfere with any aspect of study conduct or interpretation of results
18 Years
70 Years
ALL
No
Sponsors
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Neuraly, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis To
Role: STUDY_DIRECTOR
Neuraly, Inc.
Locations
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Summit Research Site
Maitland, Florida, United States
Summit Research Site
Monroe, Louisiana, United States
Summit Research Site
West Monroe, Louisiana, United States
Summit Research Site
Kansas City, Missouri, United States
Summit Research Site
Austin, Texas, United States
Summit Research Site
Bellaire, Texas, United States
Summit Research Site
Brownsville, Texas, United States
Summit Research Site
Corpus Christi, Texas, United States
Summit Research Site
Edinburg, Texas, United States
Summit Research Site
Georgetown, Texas, United States
Summit Research Site
San Antonio, Texas, United States
Summit Research Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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DD01-DN-02
Identifier Type: -
Identifier Source: org_study_id
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