Recruiting
Phase 2

NAD Augmentation

Sponsor:

Brigham and Women's Hospital

Code:

NCT05759468

Conditions

Type2diabetes

Diabetic Kidney Disease

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Investigational Product - MIB 626

Placebo

Study Details

Brief summary:

A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.

Conditions

Type2diabetes

Diabetic Kidney Disease

Study ID

NCT05759468

Start date

Apr 13, 2023

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH > 20 U/L), 30 years or older
2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:

1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.
2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.
3. HbA1c >6.4%; or 2 fasting glucose > 125 mg/dL
3. Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit.

a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.
4. If type 2 diabetic and UACR is > 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.
5. eGFR > 25 mL/ min / 1.73 m2
6. Hemoglobin A1c <10%
7. Able to speak English or Spanish or Haitian Creole
8. Willing and able to provide written informed consent
9. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.

Exclusion criteria:

1. Fasting morning UACR > 5,000 mg/ g creatinine
2. Other laboratory abnormalities:

1. Has AST or ALT > 3 times the upper limit of normal
2. eGFR < 25 mL/ min / 1.73 m2
3. Hematocrit < 0.34 or > 0.50 L/L
3. A major adverse cardiovascular event in preceding 3 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. Current alcohol or substance use disorder or dependence (DSM 5 criteria).
6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
8. Has a history of anaphylaxis from vitamin B3 derivatives
9. BMI > 42.5 kg/ m2
10. If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Investigational Product - MIB 626

The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily.

placebo comparator: Placebo

Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.

Interventions

Investigational Product - MIB 626

The eligible participants will be assigned to receive either NMN or placebo using concealed block randomization in a 1:1 ratio, stratified by sex (male, female), age (60 to 75, >75 years) and trial site. The randomization list will be generated by the unblinded biostatistician using the software R (www.r-project.org), and deployed in a secure, centralized web-based application accessible to study staff following confirmation of a participant's eligibility.

Placebo

Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.

Primary outcome measure

  • The primary endpoint is the change from baseline in UACR over the 6-month intervention period. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Shalender Bhasin, MB BS

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 13, 2026

Last verified

Feb, 2026

Keywords

  • diabetes
  • type 2 diabetes
  • kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-04-13.