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

NCT05831644 | Completed Phase 1 Results

• 2 other identifiers: VP-C21-0132023-000168-77
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2diabetes; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamic Effect

  Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). The EndoPAT software, provided with the device, is calculating the RHI using a computerised, automated algorithm. Reactive Hyperemia Index (RHI) score is a post-to-pre occlusion pulse amplitude tonometry signal ratio in the occluded arm relative to the same ratio in the control arm, and corrected for baseline vascular tone. RHI is a measure of endothelial function. Normal value: RHI \> 1.67. Abnormal value: RHI ≤ 1.67. There is no theoretical minimum and/or maximum values for the RHI score. A lower RHI score following C21 compared to placebo is the desired outcome.

  Maximum 15 days after first Investigational Medical Product (IMP) intake.

Secondary Outcomes (1)

• Augmentation Index (AI) Score as Measured by EndoPAT (Endothelial Pulse Amplitude Tonometry (PAT)). The AI Score Reported is Change Between Baseline Value and Value at the Visit Where Either C21 or Placebo is Taken.

  Maximum 15 days after first Investigational Medical Product (IMP) intake.

Study Arms (2)

Treatment arm 1

EXPERIMENTAL

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

Drug: C21

Treatment arm 2

EXPERIMENTAL

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

Drug: C21

Interventions

C21 DRUG

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

Treatment arm 1; Treatment arm 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vicore Pharma AB: lead

Study Sites (1)

Skånes universitetssjukhus

Malmo, 20502, Sweden

Location

MeSH Terms

Interventions

compound 21

Results Point of Contact

• Title: Director Clincial Operations
• Organization: Vicore Pharma AB

info@vicorepharma.com

+46 (0) 31 788 05 60

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 26, 2023
• Study Start: March 31, 2023
• Primary Completion: June 16, 2023
• Study Completion: June 20, 2023
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Locations

SE (1)