Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sitagliptin · 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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Sitagliptin is an investigational small molecule being developed for the treatment of Type II Diabetes. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with Type II Diabetes.
Sitagliptin is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this investigational drug for the treatment of Type II Diabetes.
Sitagliptin is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of Type II Diabetes.
Sitagliptin has one completed clinical trial registered under NCT01619332, titled "Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763." This Phase 1 study enrolled 220 participants with Type II Diabetes in the United States and was placebo-controlled and double-blind.
Sitagliptin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type II Diabetes. The drug has completed one Phase 1 trial, but it has not yet demonstrated sufficient evidence of safety and efficacy to receive regulatory approval.