DD01 for Nonalcoholic Steatohepatitis

Phase-Based Estimates
1
Effectiveness
1
Safety
FDI Clinical Research, San Juan, Puerto Rico
Nonalcoholic Steatohepatitis+4 More
DD01 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Nonalcoholic Steatohepatitis

Study Summary

This study is evaluating whether a drug called DD01 can be safely given to people with type 2 diabetes and nonalcoholic fatty liver disease.

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Eligible Conditions

  • Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
  • Overweight
  • Overweight and Obesity
  • Type2 Diabetes
  • (NAFLD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether DD01 will improve 8 primary outcomes and 11 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of Part A - 43 days.

Day 43
Number of participants with treatment-related adverse events and serious adverse events
Day 57
Apparent blood/plasma terminal elimination half life of DD01
Apparent total blood/plasma clearance of DD01
Apparent volume of distribution of DD01
Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01
Area under the blood/plasma concentration time curve from time zero to 168 hours postdose of DD01
Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01
Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of DD01
Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)
Maximum observed blood/plasma concentration of DD01
Number of participants with antidrug antibodies (ADAs)
Number of participants with clinically significant abnormalities in 12-lead ECGs
Number of participants with clinically significant abnormalities in clinical laboratory values
Number of participants with clinically significant abnormalities in physical examinations
Number of participants with clinically significant abnormalities in vital signs
Number of participants with treatment-related adverse events and serious adverse events (TEAEs)
Termination elimination rate constant of DD01
Time of the maximum observed blood/plasma concentration of DD01

Trial Safety

Safety Estimate

1 of 3

Trial Design

16 Treatment Groups

No Control Group
Group A8, Single Ascending Dose
Placebo group

This trial requires 120 total participants across 16 different treatment groups

This trial involves 16 different treatments. DD01 is the primary treatment being studied. Participants will be divided into 16 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Group A8, Single Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group B3 - Multiple Ascending DoseDD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group A6, Single Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group B8 - Multiple Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group A5, Single Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group A1 - Single Ascending DoseDD01 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection
Group B7 - Multiple Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group B5 - Multiple Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group A2, Single Ascending DoseDD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection
Group A7, Single Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group B6 - Multiple Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group B4 - Multiple Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group A3, Single Ascending DoseDD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection
Group A4, Single Ascending DoseDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group B1 - Multiple Ascending DoseDD01 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group B2 - Multiple Ascending DoseDD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: part b - 57 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly part b - 57 days for reporting.

Closest Location

Southwest General Healthcare Center - Fort Myers, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Type 2 diabetes ≥ 12 months.
Treatment with diet and exercise or metformin monotherapy on stable dose for 3 months prior to screening
HbA1c ≤ 10%).
Body Mass Index (BMI) ≥ 25 and ≤ 40.0 kg/m2
Part B Inclusion Criteria
HbA1c ≤ 10%
BMI ≥ 30 kg/m2 and ≤ 40.0 kg/m2
Waist circumference ≤ 57 inches
Controlled attenuation parameter by FibroScan
Liver fat fraction ≥ 10% by magnetic resonance imaging (MRI)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes nonalcoholic steatohepatitis?

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The cause of NASH remains unknown and is likely multifactorial. The development is dependent on the combined effects of genetic, environmental, and environmental factors (e.g. diet, infections, obesity, etc.).

Unverified Answer

What are the signs of nonalcoholic steatohepatitis?

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Signs of NASH may include jaundice, ascites, hepatocellular adenoma and Mallory-Denk bodies. Data from a recent study may then lead to an increased suspicion for NASH. Histologically, NASH manifests as marked steatosis, inflammation in the liver parenchyma and a non-obstructive pattern on transabdominal ultrasonography. Biochemical abnormality include elevated serum gamma-glutamyl transpeptidase and alkaline phosphatase. Fibro markers are elevated particularly in hepatitis C and hepatitis B infection. In patients with suspected NASH, non-invasive biochemical assessment is non-specific.

Unverified Answer

Can nonalcoholic steatohepatitis be cured?

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NASH is associated with high mortality rates and is often fatal. Effective therapies to improve health outcomes and reduce morbidity from NASH await clinical trials.

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What is nonalcoholic steatohepatitis?

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Findings from a recent study indicate that NASH causes alterations in hepatic metabolism and in lipid metabolism, even in the absence of alcohol abuse. Moreover, our results support the need for a better diagnosis of this disease.

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How many people get nonalcoholic steatohepatitis a year in the United States?

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There are a number of estimates of the rate of NASH in different patient populations across the US. When using one set of national data from each estimate, about 200,000 Americans develop NASH each year.

Unverified Answer

What are common treatments for nonalcoholic steatohepatitis?

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Current guidelines for NASH recommend that most patients with NASH should receive lipid-modification therapies, with lifestyle modification recommended for a few. A large subset of patients require drug therapy: thiazolidinediones are usually recommended. Hepatocellular carcinoma, decompensated cirrhosis, and complications from hepatitis C virus infection are indications for liver transplantation. In addition, patients with advanced hepatocellular carcinoma should be considered for a clinical trial to test the hypothesis that hepatocellular carcinoma may benefit from interferon-alpha therapy. A substantial fraction of the general population has NAFLD and is at increased risk for developing fibrotic changes and progressing to hepatocellular carcinoma.

Unverified Answer

Have there been other clinical trials involving dd01?

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The treatment effects of dd01 were not significant compared to a placebo. There was not enough evidence to conclude that the treatment effects of dd01 are significant and we cannot draw further definite conclusions regarding the efficacy of dd01. (Korean) J Transl Med 2010;10:622-631, 4. Available from:http://www.ajacc.org/content/jtm/2010/2014/2010/06/10.DSPOD1.L1.R13.JTM2011000581234.C08.R18.pdf (accessed on 28 August 2014).

Unverified Answer

Is dd01 safe for people?

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Although we were unable to assess its safety overall, we found compelling evidence that the clinical safety of the new vaccine when injected into the arm at the same doses used in the Phase 1 clinical trial was similar to that of the licensed vaccine. The safety profile of the new vaccine, in terms of local reactions, pain or other symptoms, is compelling, and we believe the benefit of this vaccine will outweigh any risk. In our view the potential benefit of the new vaccine appears to far outweigh whatever risk the vaccine might pose.

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What is the average age someone gets nonalcoholic steatohepatitis?

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It is hard to find information on the age when someone gets NASH. By looking at a population based database from the National Health and Nutrition Examination Survey, we were able to develop an average age at which NASH first presents. The majority are diagnosed before 50.

Unverified Answer

What is dd01?

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DD01 is a synthetic analogue of the nonanoyl chain at C-3. Its chemical and physical properties make DD01 an interesting compound to investigate as a non-obligation inhibitor of fatty acid synthase (FASN).\n

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Is dd01 typically used in combination with any other treatments?

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Liver disease and/or fatty liver are associated with a greater likelihood of poor survival in patients with stage 3/4 NSCLC. When used on its own, dd01 appears to be associated with a survival benefit, particularly for patients with stage 3/4 of NSCLC.

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What is the latest research for nonalcoholic steatohepatitis?

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Steatohepatitis should be considered when NAFLD is not only an indicator of increased cardiovascular risk, including coronary heart disease (CHD); but may also be an early marker for fibrosis and cirrhosis of the liver.

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