Nicotinamide Mmononucleotide in Patients Undergoing CABG Surgery

NCT ID: NCT07013591

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2029-01-01

Brief Summary

The investigators will perform a phase 2a, randomized, double-blind, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery to investigate the effects of oral nicotinamide mononucleotide (NMN) administration on myocardial NAD+ concentrations and on postoperative markers of myocardial and kidney injury.

Detailed Description

This is a phase 2a, randomized, double-blind, parallel-group, placebo-controlled clinical trial in adult patients undergoing elective coronary artery bypass grafting (CABG) surgery. A total of 90 patients will be randomized 1:1:1 to placebo or to one of two dosing regimens of NMN seven days prior to surgery as follows:

Arm A: NMN 1,000 mg PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively

Arm B: NMN 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively

Arm C: Placebo PO twice daily, administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively

There are two major study aims:

Aim 1: Test the effect of oral NMN administration on myocardial NAD+ concentration.

Aim 2: Test the effect of oral NMN administration on postoperative myocardial and kidney injury parameters.

Conditions

Coronary Artery Bypass Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NMN (MIB-626) for 7 days preoperatively, on day of surgery, and for 4 days postoperatively

NMN (MIB-626) 1000 mg PO daily, for 7 days preoperatively, on day of surgery, and for 4 days postoperatively

Group Type: EXPERIMENTAL

MIB-626

Intervention Type: DRUG

An orally-administered stable crystalline tablet formulation of NMN

NMN administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively

NMN (MIB-626) 1,000 mg PO twice daily, administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively

Group Type: EXPERIMENTAL

MIB-626

Intervention Type: DRUG

An orally-administered stable crystalline tablet formulation of NMN

Placebo

Placebo administered for 7 days preoperatively, on the day of surgery, and for 4 days postoperatively

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

matching placebo tablets

Interventions

MIB-626

An orally-administered stable crystalline tablet formulation of NMN

Intervention Type: DRUG

Placebo

matching placebo tablets

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Scheduled to undergo elective isolated CABG surgery with cardiopulmonary bypass (CPB)

3. At increased risk of postoperative complications based on ≥1 of the following:

1. Age ≥65 years

2. eGFR <45 ml/min/1.73m2

3. Documented history of congestive heart failure or left ventricular ejection fraction (LVEF) ≤40% within 6 months before surgery

4. Diabetes mellitus and urine albumin-to-creatinine ratio >30 mg/g creatinine

5. Peripheral arterial disease

6. Anemia, defined as hemoglobin <10 g/dl

7. Prior cardiac surgery

Exclusion Criteria

1. Any of the following laboratory abnormalities at the time of screening:

1. ALT >3-fold the upper limit of normal

2. eGFR <30 ml/min/1.73m2 or ESKD on dialysis

3. Hemoglobin <8 g/dl

2. History of gastric bypass or malabsorption

3. Active alcohol or illicit substance use in the prior 6 months

4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter

5. Pregnant or breast-feeding

6. Unwillingness to use contraception while taking study drug and for 8 weeks after the last dose for women of reproductive age or non-sterilized male participants who are sexually active with a female partner of childbearing potential

7. Current use of niacin >100 mg/day or NMN, nicotinamide, or nicotinamide riboside at any dose

8. Conflict with other research studies

9. Any condition which, in the judgement of the investigator, might increase the risk to the participant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shalendar Bhasin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shalender Bhasin, MB, BS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hosptial

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Shalender Bhasin, MB,BS

Role: CONTACT

sbhasin@bwh.harvard.edu

617-525-9150

David E Leaf, MD

Role: CONTACT

deleaf@bwh.harvard.edu

617-732-5951

Facility Contacts

David E Leaf, MD

Role: primary

deleaf@bwh.harvard.edu

617-732-5951

Nancy Latham, PhD

Role: backup

nklatham@bwh.harvard.edu

6179999195

Other Identifiers

1U01AG089040-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P000420

Identifier Type: -

Identifier Source: org_study_id