An Early Phase 1 interventional study of Follistatin and klotho gene therapy in Healthy Adults, sponsored by Minicircle. Completed at 2 sites in 2 countries. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Minicircle · Early Phase 1, Interventional, and Prevention
The purpose of this study is to investigate the safety and efficacy of a combination klotho and follistatin gene therapy, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of this gene therapy.
Healthy participants will take part in cognitive and health testing before and after administration of plasmid-delivered nonviral klotho and follistatin gene therapy. The method of administration will be subcutaneous injection into abdominal fat deposits. Klotho and follistatin plasmid gene therapy have the potential to improve physical function, cognitive function, kidney function, body composition, epigenetic age, and subjective well being.
Note that the investigational product will be administered at a site outside of the U.S. which is not under FDA jurisdiction, and only non-treatment pre/post outcome assessments (e.g., cognitive assessments or blood sample collection) occur at the U.S. site.
Minicircle is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm includes cognitive and health battery pre- and post-intervention of the gene therapy
Genetic: Follistatin and klotho gene therapy
Injection of nonviral plasmid-delivered follistatin and klotho gene therapy
Concentration of Serum α-Klotho Measured by Enzyme-Linked Immunosorbent Assay (ELISA) (pg/mL)
Serum α-Klotho protein concentration will be quantified using a validated ELISA. Results will be determined from picograms per milliliter (pg/mL) for each participant at each time point. Higher or lower values have no inherent directionality and will be interpreted in study context.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Serum Follistatin Measured by Enzyme-Linked Immunosorbent Assay (ELISA) (pg/mL)
Serum follistatin concentration will be quantified using a validated ELISA. Results will be reported as picograms per milliliter (pg/mL) for each participant at each time point. Higher or lower values have no inherent directionality and will be interpreted in study context.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Number and Percentage of Participants Experiencing Treatment-Emergent Adverse Events as Assessed by Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Assessed through a checklist version of the PRO-CTCAE with each symptom options being none, mild, moderate, or severe. Items will be scored with 0, 1, 2, 3 respectively. Item responses will be summarized as number and percentage of participants experiencing each adverse event by system/organ class. High scores indicate highest severity of symptoms and low scores indicate no symptoms.
Time frame: Within 1 week after treatment and then 1 month, 2 months, and 3 months after treatment
Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Domain Scores (0-100)
The WHOQOL-BREF is a self-report questionnaire that includes four domains: Physical Health, Psychological, Social Relationships, and Environment. Each domain score is transformed to a 0-100 scale, with higher scores indicating better quality of life. Changes from baseline will be examined per domain.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Change From Baseline in Pattern Comparison Processing Speed Test T-Score (Mean 50 ± 10)
The Pattern Comparison Processing Speed Test measures processing speed using age-adjusted T-scores (mean 50, SD 10). Higher scores reflect faster cognitive processing. Changes from baseline will be analyzed per participant and time point.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change From Baseline in Picture Sequence Memory Test T-Score, Forms A and B (Mean 50 ± 10)
Picture Sequence Memory Test evaluates episodic memory. Each form (A and B) yields an age-adjusted T-score (mean 50, SD 10). Higher scores indicate better memory performance. Forms A and B will be averaged.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change From Baseline in Flanker Inhibitory Control and Attention Test T-Score (Mean 50 ± 10)
The Flanker Inhibitory Control and Attention Test measures inhibitory control and attention. Scores are age-adjusted T-scores (mean 50, SD 10). Higher scores indicate better performance. Changes from baseline will be analyzed per participant and time point.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change From Baseline in Dimensional Change Card Sort Test T-Score (Mean 50 ± 10)
The Dimensional Change Card Sort Test assesses cognitive flexibility. Scores are age-adjusted T-scores (mean 50, SD 10). Higher scores indicate better executive function. Changes from baseline will be analyzed per participant and time point.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change From Baseline in Picture Vocabulary Test T-Score (Mean 50 ± 10)
Picture Vocabulary Test measures receptive vocabulary. Results are expressed as age-adjusted T-scores (mean 50, SD 10), with higher scores indicating better performance. Change from baseline will be analyzed per participant and time point.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Epigenetic Biological Age Estimated From Whole-Genome Deoxyribonucleic Acid (DNA) Methylation Profiles (change from baseline) (years)
Whole-blood DNA methylation will be measured using bisulfite sequencing performed by Generation Lab. Epigenetic biological age will be computed from these methylation data using validated algorithms. Age estimates will be expressed in years. Lower epigenetic age relative to chronological age indicates younger biological status.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Timed one leg stance change from baseline (seconds)
Duration (seconds) that the participant can maintain an unsupported one-leg stance on the left and right leg separately, measured from the point of foot lift until loss of balance or foot contact with the ground.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change from baseline in number of squats performed (count)
Total number of full squats the participant can complete with proper form within a continuous, unassisted trial, measured from the start of movement until the participant stops or is unable to continue.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change from baseline in number of push-ups performed (count)
Total number of standard push-ups completed with proper form in a continuous trial, counted from the first repetition until the participant stops or is unable to continue.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Number of sit-ups performed (change from baseline) (count)
Total number of sit-ups the participant can complete with proper form in a continuous trial, measured from the first repetition until the participant stops or is unable to continue.
Time frame: From 1 month prior to treatment to 3 months after treatment (4 timepoints)
Change from Baseline: Concentration of High-Sensitivity C-Reactive Protein (hs-CRP) Measured by Immunoturbidimetric Assay (mg/L)
hs-CRP will be measured using an immunoturbidimetric assay and expressed in mg/L. hs-CRP is a marker of systemic inflammation and cardiovascular risk.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Ionized Calcium Measured by Ion-Selective Electrode (mmol/L)
Ionized calcium will be measured using an ion-selective electrode analyzer. Results will be reported in millimoles per liter (mmol/L) and represent physiologically active calcium fraction.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Serum Cystatin C Measured by Immunoassay (mg/L)
Serum Cystatin C will be measured using a standardized immunoassay and reported in mg/L for each participant and time point. Cystatin C is a biomarker of glomerular filtration rate and provides a mechanistic link between α-Klotho activity and renal function.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Serum Phosphorus Measured by Clinical Chemistry Analyzer (mg/dL)
Serum inorganic phosphorus will be measured on a standard clinical chemistry analyzer. Results will be reported in mg/dL for each participant and time point. Phosphorus levels reflect systemic phosphate homeostasis influenced by α-Klotho and FGF23 activity.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Urinary Phosphate Excretion Measured by Clinical Chemistry Assay (mg/24 h or mg/g Creatinine)
Urinary phosphate will be assessed using a validated chemistry assay. Will be expressed either as total phosphate excretion in milligrams per 24 hours (mg/24 h) or as the phosphate-to-creatinine ratio (mg phosphate per g creatinine). This measure reflects renal handling of phosphate and functional effects of α-Klotho on phosphate excretion.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Intact Parathyroid Hormone Measured by Two-Site Immunoassay (pg/mL)
Intact Parathyroid Hormone (PTH) will be measured in serum using a two-site immunoassay that detects the full-length molecule. Results will be reported in picograms per milliliter (pg/mL) per participant and time point. PTH reflects parathyroid activity within the α-Klotho-FGF23-vitamin D feedback pathway.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Serum 1,25-Dihydroxyvitamin D (Calcitriol) Measured by Liquid Chromatography-Tandem Mass Spectrometry (pg/mL)
Serum 1,25-dihydroxyvitamin D (calcitriol) will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Concentrations will be expressed in picograms per milliliter (pg/mL). This hormone regulates calcium and phosphate balance and is a downstream marker of α-Klotho-FGF23-PTH axis modulation.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Comprehensive Metabolic Panel (Safety Laboratory Assessment)
A standard comprehensive metabolic panel (CMP) will be collected to evaluate general metabolic and organ function for safety monitoring. The standard panel includes 14 markers: Glucose, calcium, sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine (serum), albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, and total bilirubin. Individual components will be assessed clinically to ensure no major changes to health stability but these will not analyzed as specific study endpoints.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Concentration of Platelet Factor 4 (PF4) Measured by Enzyme-Linked Immunosorbent Assay (ELISA) (ng/mL or OD Units)
Platelet Factor 4 (PF4) will be measured using a validated ELISA and reported as nanograms per milliliter (ng/mL) or optical density (OD) units. PF4 is a marker of platelet activation and potential immune-mediated coagulation effects.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Cardio IQ® Fibrinogen Antigen (mg/dL)
Fibrinogen antigen concentration will be measured by nephelometry using the Cardio IQ® assay. Reported in milligrams per deciliter (mg/dL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Hemoglobin A1c (%) change from baseline
Hemoglobin A1c (HbA1c) will be measured by standardized assay methods and reported as percent (%). Estimated average glucose (eAG) will be reported alongside HbA1c for interpretability only and will be derived from the HbA1c value using a validated conversion formula. eAG is not independently measured. Change from baseline HbA1c will be reported as a percentage and the corresponding eAG value will be included for interpretability.
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Homocysteine change from baseline (µmol/L)
Plasma homocysteine concentration will be measured by immunoassay or chromatography-based methods and reported in micromoles per liter (µmol/L).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Asymmetric and Symmetric Dimethylarginine (ADMA/SDMA) change from baseline (µmol/L)
Plasma ADMA and SDMA will be quantified by mass spectrometry-based assay and reported in micromoles per liter (µmol/L).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Serum Interleukin-6 (IL-6) change from baseline (pg/mL)
Serum IL-6 levels will be measured by high-sensitivity immunoassay and reported in picograms per milliliter (pg/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Tumor Necrosis Factor-α (TNF-α) change from baseline (pg/mL)
Serum TNF-α concentration will be measured by immunoassay and reported in picograms per milliliter (pg/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Serum Interleukin-1β (IL-1β) change from baseline (pg/mL)
Serum IL-1β levels will be quantified using a cytokine immunoassay and reported in picograms per milliliter (pg/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Serum Interferon-γ (IFN-γ) (pg/mL)
Plasma IFN-γ concentration will be measured using an immunoassay and reported in picograms per milliliter (pg/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Serum Interleukin-10 (IL-10) (pg/mL)
Serum IL-10 levels will be measured by cytokine immunoassay and reported in picograms per milliliter (pg/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Myostatin (ng/mL)
Serum myostatin concentration will be measured using a validated immunoassay and reported in nanograms per milliliter (ng/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Activin A (pg/mL)
Serum activin A will be quantified by immunoassay and reported in picograms per milliliter (pg/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Insulin-Like Growth Factor-1 (IGF-1) (ng/mL)
Serum IGF-1 will be measured using a standardized immunoassay with age-adjusted calibration and reported in nanograms per milliliter (ng/mL).
Time frame: From 1 month prior to treatment to 3 months after treatment (5 timepoints)
Plan to share: Yes — Individual participant data will be made available along with a data dictionary describing each variable. If the study results in multiple publications, the IPD corresponding to the measures reported in each publication will be shared upon that publication. The complete trial dataset, if anything is remaining, will be made available once all results have been published. Supporting documentation shared will include study protocol, statistical analysis plan, informed consent forms, and analytic code.
Time frame: Data will be made available upon publication and will be available indefinitely.
Access criteria: Data will be made available to anyone who wishes to access it in an online repository at Zenodo (https://zenodo.org/). The types of data shared will include de-identified data of pre- and post-treatment values for the following measures: serum Klotho levels; serum Follistatin levels; kidney and blood safety panels; questionnaires and adverse event reporting data (all check box questions; however, any open-ended answer data will reviewed to ensure they cannot be used to identify an individual participant - final judgments will be made by the study central coordinator); quantitative muscle function outcomes; all NIH-toolbox measures; epigenetic age.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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