Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05826054 | Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics | PHASE1 | RECRUITING | 50 | — | — | Dec 1, 2023 | Feb 1, 2025 | Oct 15, 2024 | 1 | Canada |
The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | In this study, participants will receive increasing dosages of the Study Treatment (Montbretin A, MbA) at each treatment visit. The Study Treatment will be taken with a standardized meal (a meal that has specified quantities of carbohydrates, fats and proteins). At each visit, participants will receive one dose (in pill form) of MbA. As long as they are not experiencing any side effects, this dose will be gradually increased at each study visit (starting from 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, to 300 mg MbA). |
| Name | Type | Description |
|---|---|---|
| Montbretin A | DIETARY_SUPPLEMENT | The investigational product is 95% pure montbretin A (MbA), a glycosylated acyl-flavonol isolated from the corms (bulbs) of the Crocosmia plant through hot water extraction. It is a potent and specific inhibitor of human pancreatic amylase (HPA). |
Inclusion Criteria: * Male or female, age ≤ 65 years; ≥19 years; * Have diagnosed type-2 diabetes mellitus with HbA1C between 6.5% to 11% that is currently managed by diet and no other medications or healthy volunteers defined as not having diagnosis of type-2 diabetes mellitus. * Have routine and ...