Roche reports promising early results for experimental obesity drug CT-996
Roche (RHHBY) has announced positive top-line results from an early-stage study of its experimental obesity treatment, CT-996.
This Phase I study is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in overweight or obese adults, both with and without type 2 diabetes.
CT-996 is an investigational, once-daily, oral GLP-1 receptor agonist, aimed at treating both obesity and type 2 diabetes. The study is structured in multiple parts:
Part 1: Single ascending dose in 40 overweight participants (completed).
Part 2: Multiple ascending doses in 25 obese participants without type 2 diabetes (completed).
Part 3: Planned multiple ascending doses in 30 obese participants with type 2 diabetes, set to begin in the fourth quarter.
Initial data revealed that participants without type 2 diabetes experienced a clinically meaningful placebo-adjusted mean weight loss of 6.1% within four weeks. The drug was well tolerated, with mostly mild to moderate gastrointestinal-related side effects, consistent with the safety profile of similar incretin drugs. No unexpected safety issues or treatment discontinuations related to CT-996 were observed.
The pharmacokinetic data support a once-daily oral dosing regimen, enhancing its potential convenience for patients.
Roche entered the obesity market through its $2.7 billion acquisition of Carmot Therapeutics, gaining a portfolio of incretin-based treatments including CT-388 and CT-868. CT-388, a dual GLP-1/GIP receptor agonist, is in Phase II trials for obesity treatment. CT-868, a subcutaneous dual GLP-1/GIP receptor agonist, is also in Phase II and aims to aid glycemic control in type 1 diabetes patients.
In May 2024, Roche reported positive results from an early-stage study of CT-388, showing an 18.8% mean placebo-adjusted weight loss over 24 weeks with weekly subcutaneous injections.
Roche’s incretin-based portfolio may extend to other indications, including cardiovascular and kidney diseases, given the significant role of incretins in these conditions.
The obesity treatment market is highly lucrative, currently led by Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, both of which have seen substantial demand and sales growth. The success of these drugs has intensified competition as other companies seek to enter this promising market.