| CTRI Number |
CTRI/2026/01/100406 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Whether Bempedoic acid has any effect on hardening of arteries in Diabetic patients with Lipid abnormalities |
|
Scientific Title of Study
|
Effect of Bempedoic acid on arterial Stiffness in patients with Diabetic dyslipidemia: a Pilot Randomized controlled trial |
| Trial Acronym |
BAASID Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Naskar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
School of Tropical Medicine |
| Address |
School of Tropical Medicine
108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arindam Naskar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
School of Tropical Medicine |
| Address |
School of Tropical Medicine
108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arindam Naskar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
School of Tropical Medicine |
| Address |
School of Tropical Medicine
108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARINDAM NASKAR |
| Address |
108 CR Avenue
Kolkata 73 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARINDAM NASKAR |
School of Tropical Medicine |
108 CR Avenue
Kolkata
WEST BENGAL |
7044007741
indrani.bbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin 40 mg |
Atorvastatin 40 mg compared with Atorvastatin 20 mg with Bempedoic acid 180 mg in T2 DM patients with LDL more than 70 mhg/dl despite on Atorvastatin 20 mg for last 6 months |
| Intervention |
Intervention arm-Bempedoic Acid 180 mg add on to Atorvastatin 20 mg
|
Intervention: Bempedoic acid 180mg daily as add on therapy to Atorvastatin 20mg daily Control arm: Atorvastatin 40mg daily-In T2DM patients with LDL 70 mg/dl despite Atorvastatin 20 mg for last 6 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Established diagnosis of type 2 diabetes mellitus (T2DM) [As per American Diabetes Association criteria for diagnosis of T2DM]
Serum LDL more than 70 mg/dl with Atorvastatin (20mg daily) therapy for at least 6 months
Willing to providing written informed consent |
|
| ExclusionCriteria |
| Details |
Patients having estimated GFR less than 30 ml/min/1.73m2 by CKD-EPI criteria
Patients known Heart failure (Stage III or IV) Severe liver dysfunction (Child Pugh C)
Baseline AST and ALT more than 3 times of upper limit
Hemoglobin less than 8 gm/dl
Tobacco abusers and any kind of substance abusers Patients with malignancy and/or on chemotherapy Patients with infectious disease like HIV Hepatitis B and Hepatitis C
Hyperuricemia (Male more than 7 mg/dl, female more than 6 mg/dl)
History of Tendon rupture |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Bempedoic acid vs standard of care on arterial stiffness in patients of T2DM with LDL more than 70 mg/dl from baseline to week 24. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare any changes from baseline to week 24 in
Lipid Profile
BMI
eGFR
Urinary albumin creatinine ratio
ALT and AST |
6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A preclinical study has demonstrated Bempedoic acid may have favourable effect on arterial stiffness in male Sprague-Dawley Rats. However there is lack of human trial in existing literature to demonstrate effect of Bempedoic acid on vascular stiffness. Our study aims to frill this knowledge gap whether Bempedoic acid can actually reduce arterial stiffness that may add new insight to existing literature |