Recruiting
Phase 2

Nicotinamide Mononucleotide

Sponsor:

Brigham and Women's Hospital

Code:

NCT07013591

Conditions

Coronary Artery Bypass Graft

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MIB-626

Placebo

Study Details

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.

Conditions

Coronary Artery Bypass Graft

Study ID

NCT07013591

Start date

Jun 10, 2026

Status verified date

Jun, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

placebo comparator: Placebo

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

Interventions

MIB-626

An orally-administered stable crystalline tablet formulation of NMN

Placebo

matching placebo tablets

Primary outcome measure

  • NAD+ concentration in the myocardial tissue [ Time Frame: Intraoperatively (single time point) ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • coronary artery bypass graft
  • cardiac surgery
  • cardiopulmonary bypass
  • nicotinamide
  • NMN
  • acute kidney injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-26.