Clinical Data
The data were analyzed for the modified intent to treat patient population (mITT; 108 of 113 patients) using the mixed model repeated measures (MMRM). The mITT population includes all patients that received at least one dose of drug and had one post baseline evaluation.OPK88003 showed a strong, clinically meaningful reduction in HbA1c at 30 weeks (-1.30% versus placebo, -0.09% mean absolute reduction, p<0.0001). Additionally, 50% of OPK88003 treated patients achieved HbA1c ≤6.5% versus 13.8% of placebo treated subjects (p=0.0008).Patients treated with OPK88003 achieved a significant weight loss at 30 weeks (-4.4 kg, compared to placebo -1.8 kg, p=0.01).  Approximately 38% of treated patients achieved a 5% or greater body weight loss compared to 13% of placebo treated patients (p=0.008).OPK88003 treated patients showed significant blood triglyceride decreases from baseline. The decrease in triglycerides in the OPK88003 treatment group was -31.2 mg/dL (p=0.005) compared to -11.6 mg/dL for placebo (p=0.44).  OPK88003 treatment showed a safety and tolerability profile expected for the GLP-1 receptor agonist class.  The most frequent adverse events were nausea, vomiting and diarrhea.  These were mostly mild and occurred predominantly during the titration period and resolved over time.  No serious adverse events were observed.Based on this trial data, OPKO is planning to further evaluate OPK88003 for a Phase 3 clinical program in type 2 diabetes and obesity and potentially for other promising indications such as NASH.