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

Sponsor
Vicore Pharma AB (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05831644
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
3.2
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment arm 1

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

Drug: C21
C21 is an angiotensin II type 2 receptor agonist (ATRAG)
Experimental: Treatment arm 2

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

Drug: C21
C21 is an angiotensin II type 2 receptor agonist (ATRAG)

Outcome Measures

Primary Outcome Measures

  1. Pharmacodynamic effect [Maximum 15 days after first Investigational Medical Product (IMP) intake.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Skånes universitetssjukhus Malmö Sweden 20502

Sponsors and Collaborators

  • Vicore Pharma AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vicore Pharma AB
ClinicalTrials.gov Identifier:
NCT05831644
Other Study ID Numbers:
  • VP-C21-013
First Posted:
Apr 26, 2023
Last Update Posted:
May 2, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 2, 2023