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Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Phase 2 trial testing CP105F in Hyperlipidemias in 263 participants. Completed in 31 December 2021.
| Lead sponsor | Montreal Heart Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 263 |
| Start date | 31 May 2019 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Canada |
Montreal Heart Institute
18 and older, any sex, with Hyperlipidemias. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
mg/dL
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -3.80 | -13.13 – 5.54 |
| Oat Beta-glucan 1.5g | 2.95 | -2.93 – 8.83 |
| Oat Beta-glucan 3g. | 4.36 | -3.38 – 12.10 |
| Oat Beta-glucan 6g. | -1.70 | -8.88 – 5.47 |
Time frame: The time period covered was from the first dose of IP to safety follow-up visit (week 14).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Oat Beta-glucan 1.5g | Oat Beta-glucan 3g. | Oat Beta-glucan 6g. |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Transient Ischemic Attack | Nervous system disorders | — | — | — | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Placebo | Oat Beta-glucan 1.5g | Oat Beta-glucan 3g. | Oat Beta-glucan 6g. |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | — | — | — | — |
| Abdominal Distension | Gastrointestinal disorders | — | — | — | — |
| Abdominal Discomfort | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Faeces soft | Gastrointestinal disorders | — | — | — | — |
| Frequent bowel movements | Gastrointestinal disorders | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Herpes Zoster | Infections and infestations | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Abdominal Pain Upper | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Hypoaesthesia | Nervous system disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Diabetes Mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Infrequent bowel movements | Gastrointestinal disorders | — | — | — | — |
| Rectal tenesmus | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
Most-reported serious reactions: Myocardial Infarction, Osteoarthritis, Transient Ischemic Attack, Pulmonary Embolism.
Data from ClinicalTrials.gov NCT03857256 adverse events section.
The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of another statin on heart disease lipid risk factors.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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