Corbus Pharmaceuticals (CRBP) Study result summary

Study background and design

• CANYON-1 was a double-blind, placebo-controlled, dose-ranging Phase 1b trial in 254 obese, non-diabetic adults at 15 US sites, with three dose levels (20, 40, 60 mg) and a placebo arm.

• The study population had an average BMI of 37, with 71% female participants, reflecting the broader U.S. obese population.

• Dosing lasted 12 weeks, with titration every two weeks and a 4-week observation period.

Efficacy results

• Statistically significant, dose-dependent weight loss was observed at all doses, with a 5% placebo-adjusted mean loss at 60 mg after 12 weeks and no evidence of plateauing.

• All 60 mg completers lost weight; 44.4% lost at least 5%, 6.7% lost more than 7.5%, and the highest individual loss was 13.4%.

• Efficacy was comparable to oral GLP-1 therapies in cross-trial comparisons, despite a distinct mechanism.

Safety and tolerability

• CRB-913 was generally well tolerated, with discontinuation rates (3.1%-13.1%) similar to placebo and approved oral GLP-1s.

• No severe psychiatric or GI treatment-emergent adverse events were observed; psychiatric AEs were mild or moderate, transient, and resolved, with no suicidality reported.

• GI side effects were milder and less frequent than with oral GLP-1s, especially for vomiting, constipation, and nausea.