Gout DiseasePhase 3NCT07889284
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
A Phase 3 study testing Combined metabolic activators and Collagen and maltodextrin in people with Gout Disease, run by ScandiBio Therapeutics AB at 12 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Disease
- What is being tested?
- Combined metabolic activators and Collagen and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 12 sitesTurkey (Türkiye)
- Study dates
- Oct 2026to Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- History of stroke.
- History of brain trauma < 14 days.
- Uncontrolled diagnosed depression.
- Uncontrolled diabetes (HbA1c > 8.4%).
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- Severe swallowing problems.
- PEG-feeding.
- Chronic diarrhoea.
- 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
- Active bronchial asthma at the time of screening.
- History of phenylketonuria
- Known allergy for substances used in the study
- Known allergy for strawberry
- Known active malignancy
- Known active psoriasis
- 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.
- Participants considered as inappropriate for this study for any reason (noncompliance etc.) per investigator assessment.
- 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 who are breastfeeding or pregnant at screening (as documented by a positive beta human chorionic gonadotropin [β-hCG] test)
- 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.
- Currently has secondary hyperuricemia:
- 1) 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.
- Dietary and physical therapy for the underlying disease
- Drugs or containing compound preparations that potentially affect SUA level:
- Immunosuppressants (mizoribine, cyclosporin, tacrolimus hydrate)
- Antituberculous drugs (pyrazinamide, ethambutol hydrochloride)
- Hyperlipidemia drugs (fenofibrate, atorvastatin, rosuvastatin, pitavastatin)
- Antihypertensives (losartan potassium)
- Diuretics (thiazide diuretics, loop diuretics)
- Sodium-dependent glucose transporter (SGLT) 2 inhibitors
- Theophylline
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Turkey (Türkiye)12 sites
Alanya Training and Research Hospital
Alanya
Şakir Özgür Keskek
Şakir Özgür Keskek, Prof. Dr.
Ankara Bilkent City Hospital
Ankara
Hakan Babaoğlu
Hakan Babaoğlu, Assoc. Prof. Dr.
Atatürk University Research Hospital
Atatürk
Bülent Albayrak
Bülent Albayrak, Assoc. Prof. Dr.
Erzurum City Hospital
Erzurum
Kenan Çadırcı
Kenan Çadırcı, Prof. Dr.
Eskişehir Osmangazi University Faculty of Medicine Hospital
Istanbul
Nazife Şule Bige Yaşar
Nazife Şule Bige Yaşar, Prof. Dr.
Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul
Esen Kasapoğlu
Esen Kasapoğlu, Prof. Dr.
Istanbul University-Cerrahpaşa Faculty of Medicine Hospital
Istanbul
Gülen Hatemi
Gülen Hatemi, Prof. Dr.
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul
Ozan Cemal İçaçan
Ozan Cemal İçaçan, Specialist. Dr.
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul
Mehmet Engin Tezcan
Mehmet Engin Tezcan, Specialist. Dr.
Koç University Hospital
Istanbul
Gökhan Gönenli, mgonenli@ku.edu.tr
Gökhan Gönenli, Specialist. Dr.
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul
Kadem Arslan
Kadem Arslan, Assoc. Prof. Dr.
Sultan 2nd Abdülhamid Han Training and Research Hospital
Istanbul
Memnune Sena Ulu
Memnune Sena Ulu, Prof. Dr.
About this study
Official title: 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.
Read the detailed description
Consenting participants will be screened for eligibility (Visit 1; screening) according to study-specific eligibility criteria within 7 days prior to randomisation and start of investigational medicinal product (IMP) administration.
Eligible participants will be randomised on Day 1 (Visit 2) to 4 weeks of twice daily (b.i.d.) oral treatment of either CMA2 or placebo (1:1). The first dose will be administered at the study clinic. The participants will be observed for 2 hours post dose for the development of any allergic reactions or intolerance after taking the first dose.
Visits at the study site will be performed at Day 1 (Visit 2), Day 14 (Visit 4) and Day 28 (Visit 6; end of in study treatment). There will be telephone follow up visits at Day 7 (Visit 3) and Day 21(Visit 5) checking safety, concomitant medications and IMP compliance. A final follow-up visit for safety assessments will be conducted in a subgroup of patients 14 days after the end of treatment (Day 42; Visit 7) during an IMP-free follow-up period to assess safety and concomitant medications.
The following clinical scales will be used to evaluate the effect of CMA2 on uric acid decline, hsCRP and daily life activity: Serum Uric Acid Levels, hsCRP, number of flares according to the GAFFO criteria, HAQ-DI, SF-36, PGA (100 mm).
Plasma samples will be collected for advanced metabolomics, proteomics, and lipidomics analysis.
Optionally, synovial samples will be collected for advanced metabolomics, proteomics, and lipidomics analysis. Optionally, gut and saliva samples will be collected for metagenomics analysis of gut and oral microbiome.
Laboratory and clinical safety parameters will be monitored at pre-specified time-points.
- Conditions
- Gout Disease
- Being tested
- Combined metabolic activators, Collagen and maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined metabolic activatorsDrug
A total of 20g of CMA2 with strawberry aroma and colouring agent will be given. The IMP will be provided as a soluble powder packed as individual dosages in identical sachets. The powder should be dissolved in 200 ml preferably cold water before use. The powder can also be used on yoghurt or other food. The subjects will take two daily oral doses of the IMP, one dose just after breakfast and one dose just after dinner. Subjects who cannot tolerate (e.g., diarrhoea) taking full dose will be withdrawn from the study.
Collagen and maltodextrinOther
As placebo, a total of 20g of compound primarily containing collagen and maltodextrin will be administered. Placebo contains strawberry aroma flavouring and colouring agent.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Combined metabolic activators |
| Placebo Arm | Placebo comparator | Not described Receives: Other: Collagen and maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of 4-weeks administration of CMA2 treatment on serum uric acid levels in participants diagnosed with hyperuricemia associated with gout, as compared with placebo.
Absolute change in serum uric acid levels from baseline to end-of-treatment (4 weeks).
Measured: 4 weeks
Secondary outcomes (8)
To evaluate the effect of 4 weeks of CMA2 treatment on patient global assessment (PGA, 100 mm) compared with placebo.
Change in patient global assessment (PGA, 100 mm) score from baseline to end-of-treatment.
Measured: 4 weeks
To evaluate the effect of 4 weeks of CMA2 treatment on High Sensitivity C-reactive Protein (hsCRP) levels compared with placebo.
Percentage change in High Sensitivity C-reactive Protein (hsCRP) levels from baseline to end-of-treatment.
Measured: 4 weeks
To evaluate the proportion of participants achieving serum uric acid levels < 6 mg/dL.
Proportion of patients with a serum uric acid level <6 .0 mg/dL at end-of-treatment.
Measured: 4 weeks
To evaluate the effect of 2-weeks administration of CMA2 treatment on serum uric acid levels compared with placebo.
Change in serum uric acid levels from baseline to 2-weeks.
Measured: 2 weeks
To evaluate patient adherence to the twice-daily treatment regimen.
Percentage of expected twice-daily study drug doses successfully administered, as assessed by sachet counts.
Measured: 4 weeks
To evaluate the incidence of adverse events (AEs).
The percentage of subjects experiencing at least one AE during the study period.
Measured: 6 weeks
To evaluate the severity of AEs.
The incidence of AEs categorized by maximum severity grade.
Measured: 6 weeks
To evaluate the incidence of serious adverse events (SAEs).
The percentage of subjects experiencing at least one SAE during the study period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScandiBio Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gökhan Gönenli, Uzm. Dr. M., Principal investigator, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889284
- Sponsor's protocol ID
- SB-GOUT-001
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No