Trial Outcomes & Findings for A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes (NCT NCT05831644)

Last Updated: 2024-11-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

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

Results posted on

2024-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: C21 First, Then Placebo Participants first received a single oral dose of C21. After a washout period of 3 to 14 days, they then received a single oral dose of placebo (matching the C21 tablet).	Experimental: Placebo First, Then C21 Participants first received a single oral dose of placebo (matching the C21 tablet). After a washout period of 3 to 14 days, they then received a single oral dose of C21.
First Intervention STARTED	6	5
First Intervention COMPLETED	6	5
First Intervention NOT COMPLETED	0	0
Washout Between 1st and 2nd Intervention STARTED	6	5
Washout Between 1st and 2nd Intervention COMPLETED	6	5
Washout Between 1st and 2nd Intervention NOT COMPLETED	0	0
Second Intervention STARTED	6	5
Second Intervention COMPLETED	6	5
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: C21 First, Then Placebo n=6 Participants Participants first received a single oral dose of C21. After a washout period of 3 to 14 days, they then received a single oral dose of placebo (matching the C21 tablet).	Experimental: Placebo First, Then C21 n=5 Participants Participants first received a single oral dose of placebo (matching the C21 tablet). After a washout period of 3 to 14 days, they then received a single oral dose of C21.	Total n=11 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 7.5 • n=5 Participants	64.4 years STANDARD_DEVIATION 8.5 • n=7 Participants	64.5 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	C21 Treatment n=11 Participants Subjects received a single dose of 200 mg C21 (4 oral capsules) at Visit 2 or Visit 3.	Placebo Treatment n=11 Participants Subjects received a single dose (4 oral capsules) of placebo at Visit 2 or Visit 3.
Pharmacodynamic Effect	1.787 score on a scale Standard Error 0.062	1.911 score on a scale Standard Error 0.062

SECONDARY outcome

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

The EndoPAT software, provided with the device is calculating the the Augmentation index (AI) using a computerised, automated algorithm. Augmentation index is a measurement of vascular stiffness. Augmentation index is calculated from PAT pulses based on the following formula AIx = 100 × (Augmentation pressure)/(Pulse Pressure). Ideally the augmentation index is somewhere between 20-80, but can be both negative and positive depending on the value of the augmentation pressure. A higher value is indicative of vascular stiffness.

Outcome measures

Outcome measures
Measure	C21 Treatment n=11 Participants Subjects received a single dose of 200 mg C21 (4 oral capsules) at Visit 2 or Visit 3.	Placebo Treatment n=11 Participants Subjects received a single dose (4 oral capsules) of placebo at Visit 2 or Visit 3.
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.	15.937 score on a scale Standard Error 2.484	20.877 score on a scale Standard Error 2.484

Adverse Events

C21 Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	C21 Treatment n=11 participants at risk Subjects received a single dose of 200 mg C21 (4 oral capsules) at Visit 2 or Visit 3.	Placebo Treatment n=11 participants at risk Subjects received a single dose (4 oral capsules) of placebo at Visit 2 or Visit 3.
Infections and infestations Nasopharyngitis	18.2% 2/11 • Number of events 2 • All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.	0.00% 0/11 • All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.
Skin and subcutaneous tissue disorders Eczema	9.1% 1/11 • Number of events 1 • All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.	9.1% 1/11 • Number of events 1 • All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.
Investigations Transaminases increased	9.1% 1/11 • Number of events 1 • All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.	0.00% 0/11 • All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.

Additional Information

Director Clincial Operations

Vicore Pharma AB

Phone: +46 (0) 31 788 05 60

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place