Phase 2
N=50
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT03381287 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Mar 2023
Primary outcome: Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) — 8; 10; 8; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HTD1801 Tablets, 500 mg (Drug); HTD1801 Tablets, 1000 mg (Drug); HTD1801 Tablets, 2000 mg (Drug); Placebo to match 500 mg HTD1801 (Drug); Placebo to match 1000 mg HTD1801 (Drug); Placebo to match 2000 mg HTD1801 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HighTide Biopharma Pty Ltd
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) |
8; 10; 8; 11; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration |
0.390; 0.441; 0.865; 923; 1900; 2900 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration |
0.676; 1.510; 1.770; 962; 1900; 3370 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration |
3.5; 4.0; 4.0; 2.0; 3.0; 4.0 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration |
4.0; 4.0; 4.0; 3.0; 4.0; 3.0 | — |
| SECONDARY Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration |
9.04; 10.60; 7.79; 2.79; 8.43; 5.24 | — |
| SECONDARY Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration |
7.60; 7.53 | — |
| SECONDARY Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups |
3.624; -3.390; -1.1550; -9.296; -3.585; -7.674 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups |
1.724; -5.788; 12.798; -2.240; 36.778; 7.684 | — |
| SECONDARY Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups |
-41.743; -38.672; -41.295; -32.192; -33.153; -46.458 | — |
| SECONDARY Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups |
-4.975; -19.527; 222.4113; -13.034; 10.582; -11.239 | — |
Summary
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of HTD1801 in overweight to obese adults with hypercholesterolemia. There were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with 16 subjects planned for each cohort randomized 3:1 to receive either HTD1801 or Placebo.
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Males or females aged 18 to 70 years old at the time of first dosing
- Have a body mass index (BMI) of >25.0 and ≤ 45.0 kg/m2 at Screening
- Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L
Exclusion Criteria
- The use of any anti-dyslipidemia agent within 28 days prior to dosing
- History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L
- History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
- Significant peripheral or coronary vascular disease
- Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg
- Primary hypothyroidism (thyroid stimulating hormone [TSH] > upper limit or normal [ULN] and free T4 ULN and free T4 within normal limits [WNL]), or secondary hypothyroidism (screening TSH < LLN and free T4< LLN) at Screening
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Data sourced from ClinicalTrials.gov (NCT03381287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.