Sponsor study identifier
interventional
40
1 country
1
Study Start
October 1, 2025
Actual (reported)Primary Completion
February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this study is to learn about the safety of Niagen®Plus, an injectable form of nicotinamide riboside (NR), and to see how it affects levels of NAD+ in the blood. Niagen®Plus will be given either by subcutaneous (under the skin) or intramuscular (into the muscle) injection at two dose levels (50 mg or 100 mg). The main questions this study aims to answer are: Is Niagen®Plus safe and well-tolerated when given by injection several times over 100 days? How do NAD+ levels in blood change after repeated doses of Niagen®Plus? What are participants' and clinicians' experiences with the injections? Researchers will also look at changes in fatigue, sleep, quality of life, inflammation markers, mitochondrial efficiency, and perceived skin appearance. Participants will: Receive three injections in clinic on Days 1-3, followed by a Day 10 follow-up visit Self-inject Niagen®Plus at home three times per week from Days 10-100 Return to the clinic on Days 40 and 100 for safety and laboratory testing Complete short surveys about fatigue, sleep, and overall well-being throughout the study The study will include 40 generally healthy adults and will last about 100 days per participant.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2025
Actual (reported)November 3, 2025
Actual (reported)November 26, 2025
Actual (reported)February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence and severity of adverse events
The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.
From Day 1 (first injection) through Day 100 (final visit)
Blood Pressure
Blood pressure, systolic and diastolic, will be measured
Immediately before the first intervention, and through the 100th day of the study.
Heart Rate
Heart rate will be measured.
Immediately before the intervention and through the 100th day of the study (final visit).
Pulse Rate
Pulse rate will be measured.
Immediately before and through the 100th day of the study (final visit).
Respiratory Rate
Respiratory rate will be measured.
Immediately before and through the 100th day of the study (final visit).
Change in whole-blood NAD⁺ concentrations
Baseline (Day 1) through Day 100
Participant- and clinician-reported injection-site experience
Immediately post-injection through 180 minutes after dosing (Days 1-3)
Participants receive 50 mg Niagen®Plus administered subcutaneously (under the skin) once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.
Participants receive 100 mg Niagen®Plus administered subcutaneously once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.
Pharmaceutical-grade nicotinamide riboside chloride (NRCl), compounded for sterility and reconstituted in bacteriostatic water for injection. Administered by subcutaneous or intramuscular injection at 50 mg or 100 mg per dose. Participants receive three clinician-administered injections during clinic visits on Days 1-3, followed by at-home subcutaneous self-administration three times per week (Monday, Wednesday, Friday) from Days 10-100, depending on study arm.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
BTT Medical Institute Aventura North
Miami, Florida, 33180, United States
Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.
First Submitted
November 3, 2025
First Posted
November 26, 2025
Study Start
October 1, 2025
Actual (reported)Primary Completion
Blood Oxygen
Blood oxygen level will be measured.
Immediately before and through the 100th day of the study (final visit).
Complete Blood Count
A complete blood count with differential will be evaluated through whole blood samples
Immediately before and through the 100th day of the study (final visit).
Comprehensive Metabolic Panel
Comprehensive metabolic panel will be evaluated through whole blood samples
Immediately before and through the 100th day of the study (final visit).
Homocysteine
Homocysteine will be measured from venous blood samples as part of the primary safety laboratory panel. Levels will be analyzed as absolute values and change-from-baseline to evaluate any clinically significant elevations or shifts associated with repeat dosing of Niagen®Plus.
Immediately before and through the 100th day of the study (final visit).
High-Sensitivity C-Reactive Protein (hs-CRP)
High-sensitivity C-reactive protein will be assessed from venous blood samples as part of the primary safety laboratory panel. hs-CRP is a sensitive biomarker of systemic inflammation and may signal acute or sub-acute inflammatory responses to repeated Niagen®Plus dosing. Levels will be analyzed as absolute values and change-from-baseline to identify any clinically meaningful elevations or trends. Data will be summarized descriptively by dose and route of administration to support safety evaluation.
Immediately before and through the 100th day of the study (final visit).
Participants receive 50 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.
Participants receive 100 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.
Contact the study team to confirm eligibility.
February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 26, 2025
Record last verified: 2025-11
Individual participant data (IPD) will not be shared. De-identified aggregate data and summary results will be shared with the sponsor and may be included in publications or presented at scientific meetings.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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