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Anti-obesity Agent

DD01 for Fatty Liver Disease

Phase 2
Recruiting
Research Sponsored by Neuraly, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female, 18 to 70 years of age
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)
Must not have
With heart failure (New York Heart Association Class III or IV) or any cardiovascular event or evidence of active cardiovascular disease
A history of active or chronic liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 48 weeks
Awards & highlights

Summary

This trial is testing a new treatment for overweight or obese patients with liver diseases related to metabolic dysfunction.

Who is the study for?
This trial is for overweight or obese individuals who have a liver condition known as MASLD/MASH, which is often linked to excess fat in the liver without heavy alcohol use. Specific criteria for joining are not provided here.Check my eligibility
What is being tested?
The study tests DD01, a potential new treatment against a placebo (a substance with no active drug) to see its effects on patients with fatty liver diseases related to metabolic issues like obesity.See study design
What are the potential side effects?
Potential side effects of DD01 aren't listed, but common ones for treatments targeting metabolic and liver conditions may include gastrointestinal discomfort, fatigue, headache, and possible liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My waist size is within the required range for my gender.
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I am not pregnant, breastfeeding, or have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart failure or active heart disease.
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I have a history of liver disease.
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I have advanced liver disease with a history of serious liver-related health issues.
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I have not had major surgery in the last 3 months.
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I have had surgery for obesity and have significant gut issues.
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I have type 1 diabetes or type 2 diabetes treated with specific medications.
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My blood pressure or cholesterol levels are not well-controlled.
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I or my family have a history of medullary thyroid cancer.
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I have a history of kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF
Secondary outcome measures
Absolute change in percent liver fat content as assessed by MRI-PDFF
Change in glucose metabolism parameters
Change in liver biochemistry
+5 more
Other outcome measures
Histologic evidence for improvements in MASH

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DD01Experimental Treatment1 Intervention
Study Drug
Group II: PlaceboPlacebo Group1 Intervention
Matching Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DD01
2021
Completed Phase 1
~260

Find a Location

Who is running the clinical trial?

Neuraly, Inc.Lead Sponsor
4 Previous Clinical Trials
626 Total Patients Enrolled
Dennis ToStudy DirectorNeuraly, Inc.
~45 spots leftby Mar 2025