Roche Holdings AG presented encouraging topline data from the CT388-103 Phase 2 study of its investigational compound CT-388, designed to combat obesity. CT-388 is a once-weekly, subcutaneous injectable medication functioning as a dual receptor agonist for GLP-1 and GIP, developed to address obesity, type 2 diabetes, and associated comorbidities.
The clinical trial enrolled 469 adult participants characterized by obesity (body mass index, or BMI, of 30 or higher) or those overweight (BMI ranging from 27 to just under 30) with one or more weight-associated comorbidities but without a diagnosis of type 2 diabetes. The study assessed five cohorts subjected to varying dosing escalation regimens, with the maximum dose reaching 24 mg.
The study’s principal endpoint measured the percentage change in body weight from baseline to week 48. Findings indicated that weekly injections of CT-388, escalated up to 24 mg, yielded a significant and clinically relevant placebo-corrected weight reduction of 22.5% based on the efficacy estimand, with weight loss continuing beyond the 48-week time point without apparent plateauing.
A pronounced dose-dependent relationship was observed, emphasizing higher weight loss with increased dosage levels. Using the treatment regimen estimand, CT-388 achieved a placebo-adjusted weight decline of 18.3%, a result deemed statistically significant (p-value below 0.001).
On the 24 mg dose at 48 weeks, nearly 96% of treated participants lost more than 5% of their body weight. Remarkably, 87% experienced weight reductions exceeding 10%, 47.8% saw a loss over 20%, and 26.1% achieved reductions beyond 30%. Additionally, among individuals classified as pre-diabetic at the study’s start, 73% receiving the 24 mg dose normalized their blood glucose levels by week 48, compared with only 7.5% in the placebo group.
The safety profile of CT-388 was favorable, with gastrointestinal events being the most common adverse reactions, predominantly mild to moderate in severity, aligning with expectations for meds targeting incretin pathways. Treatment discontinuations attributable to adverse events were limited, recorded at 5.9% for CT-388 arms versus 1.3% in placebo.
CT-388’s progress follows Roche’s 2023 acquisition of Carmot Therapeutics, through which this therapeutic asset entered Roche’s pipeline. The company accelerated CT-388’s clinical development trajectory and granted it fast-track status, underscoring its strategic importance within Roche’s obesity treatment portfolio.
Beyond offering standalone efficacy, CT-388 is envisioned as an enabling component for combination regimens, including with petrelintide, indicating a broader role in Roche’s obesity pipeline expansion.
An ongoing Phase 2 trial, designated CT388-104, is exploring CT-388’s effects in obese participants also diagnosed with type 2 diabetes. Roche anticipates launching pivotal Phase 3 programs, named Enith1 and Enith2, in the current quarter to further evaluate the compound’s potential in obesity management.
With an increasing competitive landscape in the weight-loss pharmaceutical market, Roche’s proactive development of CT-388 aligns with its objective to establish a leadership position moving forward, directly contending with companies like Eli Lilly and Novo Nordisk.
As of the most recent trading session, Roche Holdings AG’s stock was valued at $56.12.