Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) reported topline data from its CANYON-1 Phase 1b clinical trial of CRB-913, an oral obesity treatment, showing statistically significant weight loss across all three tested doses after 12 weeks.

The double-blind, placebo-controlled study enrolled 254 obese, non-diabetic adults at 15 U.S. sites. Participants were randomized to receive 20 mg, 40 mg, or 60 mg of CRB-913 once daily, or a placebo. The 60 mg dose produced a mean weight loss of 5.0% from baseline, compared to 3.3% for the 40 mg dose and 2.8% for the 20 mg dose. The placebo group recorded no mean weight change. All active dose groups achieved p-values of less than 0.0001 versus placebo. No weight loss plateau was observed at any dose by the end of the 12-week treatment period.

Among participants in the 60 mg cohort who completed the study, all lost weight, with 44.4% losing at least 5% from baseline and 6.7% losing more than 7.5%. The highest recorded weight loss in that cohort was 13.4%.

On safety, treatment discontinuations due to adverse events ranged from 3.1% to 13.1% across CRB-913 doses. Psychiatric adverse events were described as infrequent, mild to moderate, and transient, with no serious psychiatric events or cases of suicidality reported. One case of a transient moderate depressive symptom was recorded among the 188 participants who received CRB-913. Gastrointestinal adverse events were mild or moderate, with no severe cases reported.

The company said it plans to present full data at ObesityWeek 2026, scheduled for November 14–17, 2026. Corbus also said it plans to engage with the FDA on a clinical development plan and expects to initiate a Phase 2 monotherapy study in the first half of 2027. The company is also evaluating CRB-913 in combination with GLP-1 therapy.

The information in this article is based on a press release issued by Corbus Pharmaceuticals.