NCT04797442 - Akkermansia muciniphila WST01 vs Placebo & Adiposity / Obesity or Type 2 Diabetes (T2D)

Background

Akkermansia muciniphila is a promising target for managing obesity and type 2 diabetes (T2D). However, human studies are limited.
Zhang et al. 2025 Cell Metab 37(3): 592-605

Study overview

This is a randomized clinical phase II treatment trial to study Akkermansia muciniphila WST01 or placebo in 58 enrolled participants with overweight or obese Type 2 Diabetes (T2D)
Zhang et al. 2025 Cell Metab 37(3): 592-605

Primary outcome measures

Body weight, fasting plasma glucose levels

Results

Both groups experienced reductions in body weight and glycated hemoglobin (HbA1c), with no significant differences observed between the groups. Among participants who had low baseline levels of A. muciniphila, supplementation with AKK-WST01 demonstrated high colonization efficiency and led to notable decreases in body weight, fat mass, and HbA1c, effects that were not observed in the placebo group. Conversely, in participants with high baseline levels of A. muciniphila, AKK-WST01 supplementation resulted in poor colonization and did not yield significant clinical improvements. These results were confirmed in germ-free mice that received feces containing either low or high levels of A. muciniphila.
Zhang et al. 2025 Cell Metab 37(3): 592-605

Conclusions

The metabolic benefits of A. muciniphila supplementation might rely on its initial levels in the intestine, highlighting the possibility of using gut microbiota as a guide for probiotic supplementation.
Zhang et al. 2025 Cell Metab 37(3): 592-605