Nicotinamide Mononucleotide in Patients Undergoing CABG Surgery

NCT07013591 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025P0004201U01AG089040-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• NAD+ concentration in the myocardial tissue

  NAD+ concentration in the myocardial tissue (right atrial appendage) obtained intraoperatively, measured using the validated NADome Quant assay

  Intraoperatively (single time point)

Secondary Outcomes (12)

• Intracellular levels of NAD+ and related metabolites

  Intraoperatively (single time point)

• Circulating levels of NAD+ and related metabolites

  Baseline to day 90

• Markers of cardiac injury/dysfunction

  Preoperatively, on ICU arrival, and on postoperative days 1-4

• Acute kidney injury (AKI)

  7 days post-operatively

• Serum creatinine (SCr)

  Immediately pre-operative to 7 days post-operative

Other Outcomes (5)

• Left ventricular ejection fraction (LVEF)

  change from immediately preoperative to immediate postoperative

• Atrial fibrillation

  First seven days postoperatively

• Vasoactive-inotropic score

  Immediately preoperatively to 24-hours post-incision

Study Arms (3)

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

EXPERIMENTAL

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

Drug: MIB-626

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

EXPERIMENTAL

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

Drug: MIB-626

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

matching placebo tablets

Placebo

MIB-626 DRUG

An orally-administered stable crystalline tablet formulation of NMN

NMN (MIB-626) for 7 days preoperatively, on day of surgery, and for 4 days postoperatively; NMN administered for 2 days preoperatively, on the day of surgery, and for 4 days postoperatively

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Scheduled to undergo elective isolated CABG surgery with cardiopulmonary bypass (CPB)
• At increased risk of postoperative complications based on ≥1 of the following:
• Age ≥65 years
• eGFR \<45 ml/min/1.73m2
• Documented history of congestive heart failure or left ventricular ejection fraction (LVEF) ≤40% within 6 months before surgery
• Diabetes mellitus and urine albumin-to-creatinine ratio \>30 mg/g creatinine
• Peripheral arterial disease
• Anemia, defined as hemoglobin \<10 g/dl
• Prior cardiac surgery

You may not qualify if:

• Any of the following laboratory abnormalities at the time of screening:
• ALT \>3-fold the upper limit of normal
• eGFR \<30 ml/min/1.73m2 or ESKD on dialysis
• Hemoglobin \<8 g/dl
• History of gastric bypass or malabsorption
• Active alcohol or illicit substance use in the prior 6 months
• Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
• Pregnant or breast-feeding
• 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
• Current use of niacin \>100 mg/day or NMN, nicotinamide, or nicotinamide riboside at any dose
• Conflict with other research studies
• Any condition which, in the judgement of the investigator, might increase the risk to the participant

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shalender Bhasin, MB, BS

  Brigham and Women's Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalender Bhasin, MB,BS

CONTACT

617-525-9150; sbhasin@bwh.harvard.edu

David E Leaf, MD

CONTACT

617-732-5951; deleaf@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 10, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 1 year of the end date of the study
• Access Criteria: Only de-identified data will be available for scientific research upon review of specific request and provision of IRB-approval.

Locations

US (1)