Dover, Del. – September 24, 2026 -- Clywedog Therapeutics, Inc. reported that its investigational menin inhibitor balomenib produced a placebo-adjusted mean HbA1c reduction of 0.77% at Week 12 (p0.01) and 0.70% at Week 16 (p0.05) in a Phase 1b trial, effects recorded three months after the drug's final dose following just three weeks of treatment.
Trial data show glycemic benefits persist months after dosing stops
The randomized, double-blind, placebo-controlled study (ZE63-0302-0002) enrolled 60 adults with type 2 diabetes across three countries, randomized 1:1 to balomenib or placebo for 28 days, including a pre-dosing titration week, followed by a 12-week off-treatment observation period. Participants entered with mean baseline HbA1c of 8.84% in the balomenib arm and 8.52% in the placebo arm, while taking up to three background antidiabetic agents excluding insulin. Between 28 and 30 participants per arm were evaluable at every scheduled timepoint through Week 16.
Oral glucose tolerance testing at Day 85 -- eight weeks after the last dose -- showed placebo-adjusted reductions of 203 mmol•min/L in total glucose AUC (p=0.019), 2.03 mmol/L in peak glucose (p=0.013) and 2.46 mmol/L in two-hour glucose (p=0.010), representing differences versus placebo of 11%, 11% and 15% respectively, with the two arms superimposable at baseline. Fasting plasma glucose fell by a placebo-adjusted 1.29 mmol/L (23 mg/dL) at Week 12 (p0.05).
Safety profile shows no drug-related serious events or discontinuations
The study's primary endpoint was safety and tolerability at Week 4, with glycemic control measures prespecified as exploratory. Clywedog reported no drug-related serious or severe adverse events and no therapy-related discontinuations. "The central observation is that after only a three-week course of treatment, balomenib produced sustained improvements in glycemic control consistent with a disease-modifying mechanism of action,