Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout

Trial details

Who runs it

ScandiBio Therapeutics AB

Trial code

NCT07889284

Record updated

27 October 2026

Original description

This will be a randomised, double-blind, placebo-controlled, multi-centre study with the aim to establish metabolic improvements in individuals diagnosed with hyperuricemia associated with gout by treatment with CMA2 including N-acetyl-L-cysteine (NAC), L-carnitine-L-tartrate (LCAT), nicotinamide (niacinamide), and L-serine for 4 weeks.Read full original descriptionShow less

A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Multi-centre Study to Evaluate the Efficacy, Safety, and Tolerability of Combined Metabolic Activator (CMA2) Supplementation in Individuals With Hyperuricemia Associated With Gout

This will be a randomised, double-blind, placebo-controlled, multi-centre study with the aim to establish metabolic improvements in individuals diagnosed with hyperuricemia associated with gout by treatment with CMA2 including N-acetyl-L-cysteine (NAC), L-carnitine-L-tartrate (LCAT), nicotinamide (niacinamide), and L-serine for 4 weeks.

Inclusion: Men and women ≥ 18 years of age; Individuals with elevated uric acid blood levels (7 mg/dl) and at least one episode of gout during the last three years; Diagnosis of gout based on 2015 American College of Rheumatology-European Union League Against Rheumatism (ACR-EULAR) criteria; Able to give written informed consent for participation in the study by the patient and/or legal representatives.

Exclusion: Patients who have received uric acid-lowering therapy with a change in dose within 1 month prior to inclusion; Acute gout flare within 14 days prior to randomization (i.e., any gouty arthritis episode with pain or swelling that has not fully resolved ≤14 days before randomization). Definition of Resolved (for the eligibility assessment): absence of joint pain at rest and no visible swelling at the previously affected joint(s) for at least 48 hours, and no requirement for escalation of anti-inflammatory therapy within that period; Use of dietary supplements such as vitamins, omega-3 products, or plant stanol/sterol products later than one (1) week prior to inclusion; Use of anti-microbial agents later than one (1) week prior to inclusion; Drug and/or alcohol abuse; Administration of another new chemical entity (defined as a compound that has not been approved for marketing) or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study; Females of childbearing potential who:; Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:; total abstinence (if it is their preferred and usual lifestyle); an intrauterine device or intrauterine hormone-releasing system (IUS); a contraceptive implant; an oral contraceptive (Subject must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 28 days after study drug discontinuation.); have a vasectomized partner with confirmed azoospermia. Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation; It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, ie, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide; NOTE: Females of childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal (defined as 12 months of amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) 25-140 IE/L and estradiol <200 pmol/L is confirmatory]); Male participants who:; Plan to conceive a child or donate sperm during the study treatment period and for at least 90 days after the last dose of investigational product, or; Are unwilling to use effective contraception during the study and for at least 90 days after the last dose of investigational product; Lesch-Nyhan syndrome 2) Phosphoribosylpyrophosphate synthetase superactivity 3) Congenital myogenic hyperuricemia 4) Hematopoietic neoplasms (acute leukemia, lymphoma malignant, myeloproliferative disorder, myelodysplastic syndrome, etc) 5) Solid tumors (breast cancer, seminoma, sarcoma, Wilms tumor, small cell lung cancer, etc) 6) Non-neoplastic diseases (psoriasis vulgaris, secondary polycythemia, hemolytic anemia) 7) Rhabdomyolysis 8) Hypothyroidism 9) Polycystic kidney 10) Lead poisoning/lead nephropathy 11) Down's syndrome 12) Familial juvenile gouty nephropathy 13) Hyperlactacidemia 14) Glycogen storage disease type 1 27. Participants who are on the following treatment are required to be on a stable dose and same mode of administration for at least 14 days prior to screening and to keep the stable during the study. Participants are not permitted to initiate these drugs within 14 days prior to screening and during the study; Drugs or containing compound preparations that potentially affect SUA level:; Antituberculous drugs (pyrazinamide, ethambutol hydrochloride); Hyperlipidemia drugs (fenofibrate, atorvastatin, rosuvastatin, pitavastatin); History of stroke; History of brain trauma < 14 days; History of phenylketonuria; Known allergy for substances used in the study; Known allergy for strawberry; Known active malignancy; Dietary and physical therapy for the underlying disease; Uncontrolled diabetes (HbA1c > 8.4%); Chronic kidney disease with S-creatinine > 1.30 mg/dL; Estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 in the Screening Phase; Antihypertensives (losartan potassium); Sodium-dependent glucose transporter (SGLT) 2 inhibitors; Uncontrolled diagnosed depression; Severe swallowing problems; PEG-feeding; Chronic diarrhoea; Active bronchial asthma at the time of screening; Known active psoriasis; Participants considered as inappropriate for this study for any reason (noncompliance etc.) per investigator assessment; Females who are breastfeeding or pregnant at screening (as documented by a positive beta human chorionic gonadotropin [β-hCG] test); Currently has secondary hyperuricemia:; Immunosuppressants (mizoribine, cyclosporin, tacrolimus hydrate); Diuretics (thiazide diuretics, loop diuretics); Theophylline.

ClinicalTrials.gov NCT07889284