Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CIN-107 · 7 trials · 4 indications
Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.
An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product. Any medical condition already present at enrollment should be recorded as medical history and not be reported as an AE unless the medical condition or signs or symptoms present at baseline changes in severity, frequency, or seriousness at any time during the study. In this case, it was be reported as an AE.
For this study, AESIs include the following: Events of hypotension that require clinical intervention; Abnormal potassium laboratory values that require clinical intervention; and Abnormal sodium laboratory values that require clinical intervention.
An AE was or adverse reaction is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: Death, a life-threatening AE, a persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, or an important medical event.
Mean change from baseline at Week 52 in serum potassium (mmol/L).
Mean change from baseline at Week 52 in serum sodium (mmol/L).
Change from baseline at 52 weeks in body weight (kg)
Change from baseline at 52 weeks in temperature (C)
Change from baseline at 52 weeks in seated heart rate (beats/min)
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
This PK parameter will be determined for CIN-107 using plasma concentration data.
This PK parameter will be determined for CIN-107 using plasma concentration data.
This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
Calculated as Ae/AUC. This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
This PK parameter will be calculated using the urine concentrations of CIN-107
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
This plasma PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This plasma PK parameter will be determined for metformin.
This urine PK parameter will be determined for metformin.
This urine PK parameter will be determined for metformin.
This urine PK parameter will be determined for metformin.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first dose of CIN-107, as the data permit.
This PK parameter will be determined for CIN-107 using plasma concentration data.
This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
This PK parameter will be calculated using the urine concentrations of CIN-107
| Arm | Type | Description |
|---|---|---|
| Low dose CIN-107 | EXPERIMENTAL | Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. |
| High dose CIN-107 | EXPERIMENTAL | Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks. |
| Experimental 2 mg CIN-107 tablets QD | EXPERIMENTAL | Treatment with 2 mg CIN-107 tablets, by mouth, once per day. Starting at Visit 1 and concluding at EOT (Visit 7). |
| Control (normal renal function or mild renal impairment) | EXPERIMENTAL | Estimated glomerular filtration rate (eGFR) ≥60 mL/min |
| Moderate to severe renal impairment | EXPERIMENTAL | eGFR 15 to 59 mL/min |
| Kidney failure | EXPERIMENTAL | eGFR \<15 mL/min, including: * Subjects not on dialysis; and * Subjects on dialysis, with study drug administration on a non-dialysis day |
| Treatment A: Immediate-release metformin | ACTIVE_COMPARATOR | Treatment A: single 1000 mg dose of immediate-release metformin Subjects will be randomly assigned to 1 of 2 sequences: AB or BA. * Treatment A: a single 1000 mg dose of immediate-release metformin; and * Treatment B: a single 1000 mg dose of immediate-release metformin coadministered with a 10 mg dose of CIN-107. All study medication will be administered at 8:00 AM (±2 hours). There will be a minimum 10-day washout between administration of study drug in each treatment period. |
| Treatment B: Immediate-release metformin coadministered with a CIN-107 | EXPERIMENTAL | Treatment B: a single 1000 mg dose of immediate-release metformin coadministered with a 10 mg dose of CIN-107 Subjects will be randomly assigned to 1 of 2 sequences: AB or BA. * Treatment A: a single 1000 mg dose of immediate-release metformin; and * Treatment B: a single 1000 mg dose of immediate-release metformin coadministered with a 10 mg dose of CIN-107. All study medication will be administered at 8:00 AM (±2 hours). For Treatment B, the dose of CIN-107 will be administered 2 hours prior to the dose of metformin. There will be a minimum 10-day washout between administration of study drug in each treatment period. |
| Cohort 1: 2.5 mg CIN-107 | EXPERIMENTAL | Subjects on a low salt diet |
| Cohort 2: 5.0 mg CIN-107 | EXPERIMENTAL | Subjects on a low salt diet |
| Cohort 3: 1.5 mg CIN-107 | EXPERIMENTAL | Subjects on a normal salt diet |
| Cohort 4: 2.5 mg CIN-107 | EXPERIMENTAL | Subjects on a normal salt diet |
| Cohort 5: 0.5 mg CIN-107 | EXPERIMENTAL | Subjects on a normal salt diet |
| Cohort 1: 2.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a low salt diet |
| Cohort 2: 5.0 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a low salt diet |
| Cohort 3: 1.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a normal salt diet |
| Cohort 4: 2.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a normal salt diet |
| Cohort 5: 0.5 mg matching placebo | PLACEBO_COMPARATOR | Subjects on a normal salt diet |
| Name | Type | Description |
|---|---|---|
| CIN-107 | DRUG | CIN-107 tablets by mouth once daily |
| Placebo | DRUG | Placebo tablets by mouth once daily |
| Metformin | DRUG | 1000 mg dose of immediate-release metformin |
| Matching Placebo | DRUG | A repeat oral dose of matching placebo once daily for 10 days. |
Inclusion Criteria: * Has a mean seated SBP ≥ 140 mmHg. * Has a prior diagnosis of mild-to-severe CKD. * Has an elevated UACR. * Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose. Exclusion Criteria: * H...
CIN-107 is an investigational small molecule being developed for the treatment of hypertension, including resistant hypertension and uncontrolled hypertension. It is also being studied in patients with uncontrolled hypertension and chronic kidney disease. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
The specific molecular target of CIN-107 is not disclosed in the available information. The drug is being studied for its effects on blood pressure in patients with resistant hypertension, uncontrolled hypertension, and hypertension with chronic kidney disease. Its mechanism of action has not been publicly detailed.
CIN-107 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating various forms of hypertension.
CIN-107 is currently in Phase 2 clinical development. It has completed four clinical trials, including Phase 1 and Phase 2 studies. The drug is investigational and has not received FDA approval. All completed trials were randomized, double-blind, and placebo-controlled.
CIN-107 has completed four clinical trials. These include NCT04519658 in resistant hypertension (275 participants), NCT05137002 in uncontrolled hypertension (249 participants), NCT05432167 in uncontrolled hypertension with chronic kidney disease (195 participants), and NCT05500820, a Phase 1 study in healthy subjects (56 participants). All trials are completed.
No alternative names for CIN-107 have been disclosed in the available information. The drug is referred to solely as CIN-107 in clinical trial registrations and development documentation. It is an investigational compound and not marketed under any other name.