NAD Augmentation in Diabetes Kidney Disease

NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial

NAD Augmentation in Diabetes Kidney Disease (NCT05759468) is a Phase 2 interventional studying Type2diabetes and Diabetic Kidney Disease, sponsored by Brigham and Women's Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Type2diabetes and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 140 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Type2diabetes subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Has T2DM, as indicated by any of the following: 1. Self-report of diabetes plus the use of a prescribed diabetes medication. 2. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record. 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL 2. Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days 3. If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB 4. eGFR \> 30 mL/ min / 1.73 m2 5. Hemoglobin A1c \<9% 6. Able to speak English or Spanish 7. Willing and able to provide written willing to sign a consent form 8. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months Who Should NOT Join This Trial: 1. Fasting morning UACR \> 2,000 mg/ g creatinine 2. Other laboratory abnormalities: 1. Has AST or ALT \> 3 times the upper limit of normal 2. creatinine \> 2.5 mg/dL 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. Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety. 6. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years. 7. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures. 8. BMI \> 42.5 kg/ m2 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Has T2DM, as indicated by any of the following: 1. Self-report of diabetes plus the use of a prescribed diabetes medication. 2. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record. 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL 2. Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days 3. If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB 4. eGFR \> 30 mL/ min / 1.73 m2 5. Hemoglobin A1c \<9% 6. Able to speak English or Spanish 7. Willing and able to provide written informed consent 8. 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 \> 2,000 mg/ g creatinine 2. Other laboratory abnormalities: 1. Has AST or ALT \> 3 times the upper limit of normal 2. creatinine \> 2.5 mg/dL 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. Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety. 6. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years. 7. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures. 8. BMI \> 42.5 kg/ m2

Treatments Being Tested

DRUG

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.

DRUG

Placebo

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Brigham and Women's Hospital

Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05759468), the sponsor (Brigham and Women's Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05759468 clinical trial studying?

Who can participate in NCT05759468?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05759468?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05759468. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05759468. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.