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Roche presented positive data of CT-388, a dual GLP-1/GIP receptor agonist for obesity and T2 Diabetes | iPharmaCenter

Roche unveiled encouraging results from the Phase I clinical trial of CT-388, a dual GLP-1/GIP receptor agonist in development for combating obesity and type 2 diabetes. This study revealed that a once-weekly subcutaneous injection of CT-388 over a 24-week period yielded significant weight loss among healthy adults grappling with obesity compared to a placebo.

The weight reduction attained with CT-388 was not only clinically significant but also statistically notable, boasting a mean placebo-adjusted weight loss of 18.8%.

Roche drug development in obesity and diabetes
Roche drug development in obesity and diabetes

By the 24th week, all individuals treated with CT-388 accomplished a weight loss exceeding 5%, with 85% achieving over 10%, 70% surpassing 15%, and 45% exceeding 20%.

The treatment demonstrated commendable tolerance, with gastrointestinal-related adverse events, predominantly mild to moderate, constituting the most prevalent issues, aligning with the drug class to which CT-388 belongs.

Moreover, in a subset characterized by pre-diabetes at the trial's outset, CT-388 therapy facilitated the normalization of glycemia across all patients, underscoring its profound impact on glucose regulation. No novel or unforeseen safety concerns emerged throughout the trial, affirming CT-388's safety and tolerability profile consistent with its therapeutic category.

CT-388 operates within the realm of incretin-based medications, aiming to modulate blood sugar levels and curb appetite. It selectively activates two specific receptors, GLP-1 and GIP, crucial for integrating signals derived from nutrients to regulate food intake, energy absorption, and assimilation. The dual targeting mechanism of CT-388 holds promise for eliciting enduring glucose reduction and weight loss, coupled with a favourable safety profile.

A supplementary cohort from the ongoing placebo-controlled Phase I trial of CT-388 is poised to scrutinize obese patients with type 2 diabetes (BMI>30 kg/m2) over a 12-week treatment span. Roche anticipates unveiling data from this additional cohort in the latter half of 2024.

Regarding the CT-388 study:

The CT-388-101 trial embodies a multi-arm, multi-cohort Phase I randomized, double-blind, placebo-controlled investigation devised to evaluate CT-388's safety, tolerability, pharmacokinetics, and pharmacodynamics among otherwise healthy adult participants grappling with overweight or obesity, alongside participants contending with obesity and type-2 diabetes mellitus.

The primary objective of the trial is to assess CT-388's safety and tolerability, with secondary objectives encompassing its impact on body weight and glucose homeostasis. Additionally, the trial scrutinized CT-388's pharmacokinetics and other pharmacodynamic effects.

CT-388 constitutes a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist under development for tackling obesity and type 2 diabetes (T2D). Engineered to exert potent activity on both GLP-1 and GIP receptors while minimizing or obviating ß-arrestin recruitment on either receptor, CT-388's biased signaling strategy significantly mitigates receptor internalization and ensuing desensitization, purportedly resulting in prolonged pharmacological activity. Currently, CT-388 is undergoing examination in a multi-part, multi-cohort Phase 1 clinical trial involving individuals grappling with overweight/obesity, with and without T2D.


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