Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LEZ763 · 1 trial · 1 indication
An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Adverse events will also be determined on the basis of clinical laboratory assessments, electrocardiographic evaluations and vital signs determinations.
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single dose
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single dose
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single dose
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single dose
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single and multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single dose
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single and multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after single and multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
Blood will be collected at multiple timepoints and will be analyzed for LEZ736 concentrations after multiple doses
| Arm | Type | Description |
|---|---|---|
| LEZ763 | EXPERIMENTAL | Part I- Healthy volunteers enrolled into 6 single-ascending dose cohorts Part II- Healthy volunteers enrolled into 5 multiple-ascending dose cohorts. Part III- LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner |
| Placebo | PLACEBO_COMPARATOR | Part I : Healthy volunteers enrolled in 6 single ascending dose cohorts to receive matching placebo of LEZ763. Part II: Healthy volunteers enrolled in 5 multiple ascending dose cohorts to receive matching placebo of LEZ763. Part III- Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner |
| Sitagliptin | ACTIVE_COMPARATOR | Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner |
| Sitagliptin | DRUG | Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner |
| LEZ763 | DRUG | LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner |
Inclusion criteria: * All subjects: (suggest this will reduce duplication) * Male or female aged 18-65 yr, * Subjects must weigh at least 50 kg to participate in the study. Body mass index (BMI) must be within the range of 18-37 kg/m2 (inclusive * Only postmenopausal females or female subjects who ...
LEZ763 is an investigational small molecule being developed for Type II Diabetes. It has been studied in a Phase 1 clinical trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with Type II Diabetes. LEZ763 is not approved for any indication and remains in clinical development.
LEZ763 is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 clinical trial of LEZ763 in Type II Diabetes conducted in the United States.
LEZ763 is in Phase 1 clinical development for Type II Diabetes. One Phase 1 trial has been completed, and no active trials are currently listed. LEZ763 is investigational and has not been approved by the FDA for any indication.
LEZ763 has been evaluated in one Phase 1 clinical trial, NCT01619332, titled Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763. The trial enrolled 220 participants with Type II Diabetes in the United States, was placebo-controlled and double-blind, and has been completed.
LEZ763 is an investigational small molecule developed by Novartis AG for Type II Diabetes. It has completed a Phase 1 trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics. LEZ763 has not received FDA approval and remains in clinical development.