Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program

NCT05878119 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MIB-626-206
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, placebo-controlled study in community dwelling, healthy, regularly exercising, highly physically fit men and women, 19 to 40 years. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily for 10 weeks.

Conditions

Healthy

Keywords

Healthy; Physically Fit Adults; Regularly Exercising Adults; MIB-626

Outcome Measures

Primary Outcomes (1)

• Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol

  To determine the effects of MIB-626 (microcrystalline β-Nicotinamide Mononucleotide), administered at a dose of 1000-mg twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on aerobic capacity, assessed as VO2 max measured during a standardized increasing work rate treadmill protocol, in community living, healthy, regularly exercising, highly physically fit, men and women, 19 to 40 years, inclusive.

  11 Weeks

Secondary Outcomes (11)

• Change in endurance time from baseline to week 11, measured during a constant work rate test

  11 weeks

• Change from baseline to week 11 in anaerobic threshold during CPXT

  11 weeks

• Change in upper body muscle performance, assessed as change from baseline to week 10

  10 weeks

• Change in lower body muscle performance, assessed as change from baseline to week 10

  10 weeks

• Change over the 10 weeks in performance scores on sustained-attention, reaction-timed task

  10 weeks

Study Arms (4)

Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA)

ACTIVE COMPARATOR

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.

Drug: Investigational Product - MIB 626; Other: Usual Physical Activity

Placebo plus usual physical activity (PL-UPA)

PLACEBO COMPARATOR

Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.

Drug: Placebo; Other: Usual Physical Activity

MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex)

ACTIVE COMPARATOR

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.

Drug: Investigational Product - MIB 626; Other: Standardized, progressive, high intensity, multidimensional exercise

Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex)

PLACEBO COMPARATOR

Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.

Drug: Placebo; Other: Standardized, progressive, high intensity, multidimensional exercise

Interventions

Placebo DRUG

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

Placebo plus usual physical activity (PL-UPA); Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex)

Standardized, progressive, high intensity, multidimensional exercise OTHER

Participants will be asked to perform high intensity, standardized, progressive, multidimensional exercise.

MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex); Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex)

Usual Physical Activity OTHER

Participants will be asked to perform usual physical activity per listed in the protocol

Also known as: Usual Physical Acitivty

Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA); Placebo plus usual physical activity (PL-UPA)

Investigational Product - MIB 626 DRUG

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.

Also known as: Investigational Product

Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA); MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Highly physically fit and familiar with high intensity exercise training, as indicated
• Engages in vigorous exercise regularly (4 or more days each week) for 30 minutes or longer and which includes elements of resistance exercise training
• Physically fit ascertained using Daniels' equation https://runsmartproject.com/calculator/, 5K time: ≤ 23.0 min, and/ or 10K time: ≤ 48.0 min These criteria will maximize the likelihood of including individuals with VO2max of at least 40 mL/kg/min.
• Has a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
• Willingness to engage in 10-weeks of intensive exercise training designed to improve aerobic capacity and endurance, muscle strength, power, and fatigability, anaerobic capacity, and body composition, and to reduce fatigue
• Willing to not engage in additional exercise training if randomized to the progressive exercise group and willing to not change usual physical activity if assigned to the usual physical activity group
• Is free from clinically significant medical problems as determined by the Investigator
• Is capable of providing written informed consent.
• Is willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA).
• In addition, female participants must:
• \. Not be pregnant and not planning to become pregnant over the next 6 months

You may not qualify if:

• Has AST or ALT \> 2 times the upper limit of normal
• Hematocrit \< 36% or \> 50% for men, or \< 35% to \> 48% for women
• Has a diagnosis of diabetes or is using diabetes medications or has an A1C \> 6.4%
• Serum creatinine \> 2.0 mg/dL or eGFR \<60 mL/min
• Prohibited medications and substances:
• a. Use of any performance enhancing substance (anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug
• Current use of opiates, amphetamine, cannabinoids and cocaine
• Use of any other dietary supplement during the course of the trial. Subjects who are using a supplement containing nicotinamide or niacin or nicotinamide riboside may be included if they agree to stop the supplement at least 2 weeks prior to randomization and agree not to use such supplement/s during the entire duration of the study.
• Initiation of a new pharmaceutical product during the preceding 3 months
• Known allergy to niacin or nicotinamide mononucleotide
• In the judgment of the study physician, the participant is unlikely to comply with the study protocol for any reason or it may not be safe to administer the study.
• Competing in organized athletics (e.g., collegiate sports) or training in preparation for competition
• Contraindications to magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These include: a) electrical implants such as cardiac pacemakers b) ferromagnetic implants such as aneurysm clips, surgical clips, artificial hearts valves with steel parts, shrapnel or steel implants c) ferromagnetic objects such as jewelry or metal clips in clothing d) pre-existing history of claustrophobic reactions. (Some participants who cannot undergo MRI/MRS but can undergo other study procedures might be considered on a case-by-case basis)
• For women only:
• Pregnant or planning to get pregnant over the next 6 months

Sponsors & Collaborators

• Metro International Biotech, LLC: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind in that the study participants and the study staff involved in outcomes assessments will be unaware of the intervention assignment. The randomization schedule will be masked from all study personnel except those specifically designated below. The unblinded study biostatistician The staff of the Investigational Drug Pharmacy Services. The DSMB, if requested
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Medicine, Harvard Medical School Director, Research Program in Men's Health: Aging and Metabolism Co-Director, BWH Center for Transgender Health Director, Boston Claude D. Pepper Older Americans Independence Center

Model Details: This will be two center, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: May 26, 2023
• Study Start: October 25, 2023
• Primary Completion: June 17, 2025
• Study Completion: August 4, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)