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NOT YET RECRUITING
NCT07889284
PHASE3

Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout

Sponsor: ScandiBio Therapeutics AB

View on ClinicalTrials.gov

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 L-serine for 4 weeks.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

336

Start Date

2026-10

Completion Date

2027-02

Last Updated

2026-10-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Combined metabolic activators

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 Subjects who cannot tolerate (e.g., diarrhoea) taking full dose will be withdrawn from the study.

OTHER

Collagen and maltodextrin

As placebo, a total of 20g of compound primarily containing collagen and maltodextrin will be administered. Placebo contains strawberry aroma flavouring and colouring agent.

Locations (12)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Alanya Training and Research Hospital

Antalya, Turkey (Türkiye)

Atatürk University Research Hospital

Erzurum, Turkey (Türkiye)

Erzurum City Hospital

Erzurum, Turkey (Türkiye)

Eskişehir Osmangazi University Faculty of Medicine Hospital

Eskişehir, Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

Istanbul University-Cerrahpaşa Faculty of Medicine Hospital

Istanbul, Turkey (Türkiye)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Koç University Hospital

Istanbul, Turkey (Türkiye)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Sultan 2nd Abdülhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)