A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
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| ClinicalTrials.gov Identifier: NCT03656744 |
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Recruitment Status :
Completed
First Posted : September 4, 2018
Results First Posted : December 29, 2021
Last Update Posted : December 29, 2021
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Sponsor:
HighTide Biopharma Pty Ltd
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Fatty Liver, Nonalcoholic NAFLD Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Digestive System Diseases Type 2 Diabetes Mellitus (T2DM) |
| Interventions |
Drug: HTD1801 Drug: Placebo |
| Enrollment | 101 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | 500mg HTD1801, Bid | 1000mg HTD1801, Bid | Placebo, Bid |
|---|---|---|---|
 Arm/Group Description |
HTD1801: HTD1801 tablets, 250mg | HTD1801: HTD1801 tablets, 250mg | Placebo: tablets manufactured to mimic HTD1801 tablets |
| Period Title: Overall Study | |||
| Started | 34 | 34 | 33 |
| Completed | 29 | 27 | 32 |
| Not Completed | 5 | 7 | 1 |
| Reason Not Completed | |||
| Adverse Event | 1 | 4 | 1 |
| Protocol Violation | 1 | 0 | 0 |
| Lost to Follow-up | 2 | 2 | 0 |
| Withdrawal by Subject | 0 | 1 | 0 |
| Randomized in error. Did not start investigational product. Considered an ET. | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 500mg HTD1801, Bid | 1000mg HTD1801, Bid | Placebo, Bid | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
HTD1801: HTD1801 tablets, 250mg | HTD1801: HTD1801 tablets, 250mg | Placebo: tablets manufactured to mimic HTD1801 tablets | Total of all reporting groups | |
| Overall Number of Baseline Participants | 33 | 34 | 33 | 100 | |
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Baseline Analysis Population Description |
One-hundred one subjects were randomized into the study, however, subject did not receive investigational study drug and was not included in the efficacy or safety analyses data sets.
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 33 participants | 34 participants | 33 participants | 100 participants | |
| 58 (10.2) | 53 (12.2) | 58 (10.7) | 56 (11.2) | ||
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[1]
Measure Analysis Population Description: One subject was randomized in error and did not receive investigational study drug.
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 33 participants | 34 participants | 33 participants | 100 participants | |
| Female |
26 78.8%
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24 70.6%
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22 66.7%
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72 72.0%
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| Male |
7 21.2%
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10 29.4%
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11 33.3%
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28 28.0%
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[1]
Measure Analysis Population Description: One subject randomized in error and did not receive investigational study medication.
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 33 participants | 34 participants | 33 participants | 100 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
1 3.0%
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1 2.9%
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0 0.0%
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2 2.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
3 9.1%
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2 5.9%
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0 0.0%
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5 5.0%
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| White |
29 87.9%
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31 91.2%
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31 93.9%
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91 91.0%
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| More than one race |
0 0.0%
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0 0.0%
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2 6.1%
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2 2.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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[1]
Measure Analysis Population Description: One subject randomized in error and did not receive investigational study drug.
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All Randomized Subjects
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 33 participants | 34 participants | 33 participants | 100 participants |
| Disposition |
33 100.0%
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34 100.0%
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33 100.0%
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100 100.0%
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| Eligible Subjects |
32 97.0%
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33 97.1%
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33 100.0%
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98 98.0%
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[1]
Measure Description: Results are reported for all subjects who signed the Institutional Review Board (IRB) approved informed consent form and were randomized into the study. One subject was randomized in error but did not receive investigational study drug and was not included in the analyses efficacy and safety datasets.
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Outcome Measures
Adverse Events
Limitations and Caveats
The study was conducted exclusively in the United States and data may not be applicable to other populations. The study enrolled subjects with presumed NASH and diabetes. Further studies to determine the effect of HTD1801 in non-diabetics may be needed. Future studies will focus on patients with biopsy confirmed NASH and use liver histology (i.e., liver biopsies) as a histological endpoint.
More Information
Results Point of Contact
| Name/Title: | Chief Medical Officer |
| Organization: | HighTide Therapeutics |
| Phone: | 314-791-0593 |
| EMail: | adibisceglie@hightidetx.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | HighTide Biopharma Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT03656744 |
| Other Study ID Numbers: |
HTD1801.PCT012 |
| First Submitted: | August 30, 2018 |
| First Posted: | September 4, 2018 |
| Results First Submitted: | May 12, 2021 |
| Results First Posted: | December 29, 2021 |
| Last Update Posted: | December 29, 2021 |