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A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes

Primary Purpose

Type2diabetes, Endothelial Dysfunction

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
C21
Sponsored by
Vicore Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type2diabetes

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1). Documented diagnosed with T2DM prior to the screening visit (Visit 1). An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1). Exclusion Criteria: Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count <500 cells/mm³). Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2). Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator. Unstable or deteriorating cardiac condition. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.

Sites / Locations

  • Skånes universitetssjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment arm 1

Treatment arm 2

Arm Description

A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3.

A single dose of placebo at visit 2 followed by a single dose C21 at visit 3.

Outcomes

Primary Outcome Measures

Pharmacodynamic effect
Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). Normal value: RHI > 1.67. Abnormal value: RHI ≤ 1.67. A lower RHI score following C21 compared to placebo is the desired outcome.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
August 3, 2023
Sponsor
Vicore Pharma AB
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1. Study Identification

Unique Protocol Identification Number
NCT05831644
Brief Title
A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes
Official Title
A Randomized, Double-blind, Placebo-controlled, 2-way Cross-over Trial Evaluating the Effect of C21 on Endothelial Dysfunction and Safety in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vicore Pharma AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes, Endothelial Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm 1
Arm Type
Experimental
Arm Description
A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3.
Arm Title
Treatment arm 2
Arm Type
Experimental
Arm Description
A single dose of placebo at visit 2 followed by a single dose C21 at visit 3.
Intervention Type
Drug
Intervention Name(s)
C21
Intervention Description
C21 is an angiotensin II type 2 receptor agonist (ATRAG)
Primary Outcome Measure Information:
Title
Pharmacodynamic effect
Description
Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). Normal value: RHI > 1.67. Abnormal value: RHI ≤ 1.67. A lower RHI score following C21 compared to placebo is the desired outcome.
Time Frame
Maximum 15 days after first Investigational Medical Product (IMP) intake.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1). Documented diagnosed with T2DM prior to the screening visit (Visit 1). An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1). Exclusion Criteria: Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count <500 cells/mm³). Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2). Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator. Unstable or deteriorating cardiac condition. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.
Facility Information:
Facility Name
Skånes universitetssjukhus
City
Malmö
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes

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