Palm Beach, Florida

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease

OBJECTIVES: The primary objective of the study is to evaluate the treatment effect of CIN-107 on systolic blood pressure (SBP) compared to placebo at week 26 in patients with uncontrolled hypertension and CKD. The secondary objectives of the study are: * To evaluate the treatment effect of CIN-107 on SBP compared to placebo at week 26 by dosing strategy * To determine the percentage of patients achieving SBP <130 mmHg after 26 weeks of treatment by dosing strategy; * To evaluate the change from baseline in urinary albumin-to-creatinine ratio (UACR) with each dosing strategy of CIN-107 compared to placebo after 26 weeks of treatment; * To evaluate the change from baseline in diastolic blood pressure (DBP) with each dosing strategy of CIN-107 compared to placebo at Week 26; * To evaluate the change from baseline in estimated glomerular filtration rate (eGFR) after 26 weeks of treatment. The pharmacodynamic (PD) objectives of the study are to evaluate the dose- response relationships of CIN-107 in patients with uncontrolled hypertension and CKD using measures of safety, PD, and/or efficacy after 26 weeks of treatment. * To evaluate the relationship between change in UACR and changes in aldosterone and renin levels with each dose strength of CIN-107 compared to placebo; * To evaluate the relationship between change in UACR and changes in blood pressure (BP) with each dose strength of CIN-107 compared to placebo; * To evaluate the relationship between the change in eGFR and changes in BP with each dose strength of CIN-107 compared to placebo. * To determine the changes from baseline on the PD variables of each dose strength of CIN-107 compared to placebo. The pharmacokinetic (PK)-PD objectives of the study are to evaluate the exposure-response relationships of CIN-107 in patients with uncontrolled hypertension and CKD using measures of safety, PD, and/or efficacy. The safety objectives of the study are: * To evaluate treatment-emergent adverse events (TEAEs); * To evaluate treatment-emergent adverse events of interest (AEOI) * To evaluate TEAEs leading to premature discontinuation of study drug; * To evaluate treatment-emergent marked laboratory abnormalities; and * To evaluate the change in standing SBP and DBP (measured pre-dose at the clinical site) from baseline to End of Treatment (Visit 11); and * To evaluate vital signs, standing BP and heart rate, physical examinations, electrocardiography, weight measurement, and clinical laboratory evaluations

An early Feasibility Study to Evaluate the Safety and Functionality of an Individual Accruing Data Algorithm with LY3209590 in Adult Participants with Type 2 Diabetes

Study I8H-MC-BDCT (BDCT) is a multicenter, non-randomized, open-label, parallel, early feasibility study with two sequential cohorts. The study is designed to evaluate the safety and functionality of the investigational IADA for LY3209590 in adult participants with T2D that are currently treated with basal insulin or are insulin naive. Cohort 1 and Cohort 2 will have approximately 15 participants from each T2D treatment population. During Cohort 1, participant-level glucose, hypoglycemia, LY3209590 dosing data and investigator dose recommendation overrides will be reviewed in conjunction with IADA functionality. Based on findings from these reviews, changes to further optimize safety and functionality may be made to the IADA prior to initiation of Cohort 2. Any changes will be thoroughly assessed via simulations and verification and validation testing. The same clinical controls including close investigator follow-up and the ability for investigators to override any dose recommendations will remain in Cohort 2. If any new risks identified between cohorts, then the protocol will be amended. Each cohort will consist of 4 periods and will have the same Schema and Schedule of Activities : * Study Period 1: screening, up to 4 weeks * Study Period 2: lead-in, approximately 2 weeks * Study Period 2: treatment period, approximately 16 weeks * Study Period 3: safety follow-up period, approximately 5 weeks

Ascend-Nash: A Phase 2b, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Crv431 In Adult Subjects With Nonalcoholic Steatohepatitis And Advanced Liver Fibrosis

Duration: Duration of study is 64 weeks and consists of 3 phases: • 60 days screening and randomization (8 weeks) • 365 days treatment (52 weeks) • 30 days follow-up (4 weeks) Compensation: 10 Visits- $100 MRE Imaging- $100 Liver Biopsy- $225 Total- $1,325 Screening Visit: Informed Consent, Demographics, I/E Criteria, Medical History, Vitals, Concomitant Meds, Physical Examination, ECG, Labs, Pregnancy Test. Study Medication: Subjects will be randomized 1:1:1:1 Ratio: (Stratified by presence or absence of DMT2, Fibrosis stage and maximum of 34 F2) Cohort A- Rencofilstat 75mg QD Cohort B- Rencofilstat 150mg QD Cohort C- Rencofilstat 225mg QD Cohort D- Placebo