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Roche (RHHBY) Reports Positive Phase I Data on Obesity Drug
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Roche (RHHBY - Free Report) announced positive top-line results from an early-stage study on its experimental obesity candidate CT-996.
The study is a multi-part, multi-cohort phase I randomized, double-blind, placebo-controlled, single and multiple-ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-996 in otherwise-healthy adults who are overweight or obese, with and without type 2 diabetes.
CT-996 is an investigational, once-daily, oral small-molecule GLP-1 receptor agonist, being developed for the treatment of both type 2 diabetes and obesity.
Part 1 was a single ascending dose in 40 overweight participants (completed), while part 2 was a multiple ascending dose in three sequential cohorts of a total of 25 participants with obesity without type 2 diabetes (completed). Part 3 is a multiple ascending dose study in two sequential cohorts of 30 participants with obesity and type 2 diabetes (planned to be initiated in the fourth quarter).
Data from two arms of the ongoing phase I study showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of 6.1% within four weeks.
The candidate was well tolerated, with mostly mild or moderate gastrointestinal-related adverse events, consistent with the safety profile of the incretin drug class. No unexpected safety signal was observed and there wasn’t any treatment discontinuation related to the drug under study.
The pharmacokinetic data supports a once-daily oral dosing regimen for CT-996.
Year to date, Roche’s shares gained 0.1% compared to the industry’s 23.4% growth.
Image Source: Zacks Investment Research
Roche forayed into the obesity market when it acquired privately owned Carmot Therapeutics for $2.7 billion. The acquisition added a differentiated incretin portfolio with three candidates — CT-388, CT-996 and CT-868 — to its pipeline.
CT-388 is an investigational dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes. The candidate is currently in phase II. CT-868 is an investigational, once-daily, subcutaneously injected dual GLP-1/GIP receptor agonist, currently in phase II, with the potential to be a first-in-class treatment for glycaemic control as an adjunct to insulin in patients living with type 1 diabetes.
In May 2024, Roche announced positive results from an early-stage study evaluating CT-388. Over 24 weeks, patients who received this once-weekly, subcutaneously-injected drug achieved a mean placebo-adjusted weight loss of 18.8%.
Per Roche, this recently acquired incretin-based portfolio could also be expanded to other indications where incretins play a role, including cardiovascular and kidney diseases.
The obesity market is currently one of the most lucrative spaces in the healthcare sector, dominated by bigwigs like Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) . The stupendous success of Novo Nordisk’s obesity drug Wegovy put the spotlight on the obesity space.
The FDA approved Weogovy in 2021 for chronic weight management in obese or overweight adults. Since the approval, sales of the drug have been rising consistently, driven by increased demand.
Eli Lilly’s Zepbound also witnessed a strong uptake, owing to solid demand.
Given the significant market potential of obesity, other players are striving to grab a share of this pie as well.
Image: Bigstock
Roche (RHHBY) Reports Positive Phase I Data on Obesity Drug
Roche (RHHBY - Free Report) announced positive top-line results from an early-stage study on its experimental obesity candidate CT-996.
The study is a multi-part, multi-cohort phase I randomized, double-blind, placebo-controlled, single and multiple-ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-996 in otherwise-healthy adults who are overweight or obese, with and without type 2 diabetes.
CT-996 is an investigational, once-daily, oral small-molecule GLP-1 receptor agonist, being developed for the treatment of both type 2 diabetes and obesity.
Part 1 was a single ascending dose in 40 overweight participants (completed), while part 2 was a multiple ascending dose in three sequential cohorts of a total of 25 participants with obesity without type 2 diabetes (completed). Part 3 is a multiple ascending dose study in two sequential cohorts of 30 participants with obesity and type 2 diabetes (planned to be initiated in the fourth quarter).
Data from two arms of the ongoing phase I study showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of 6.1% within four weeks.
The candidate was well tolerated, with mostly mild or moderate gastrointestinal-related adverse events, consistent with the safety profile of the incretin drug class. No unexpected safety signal was observed and there wasn’t any treatment discontinuation related to the drug under study.
The pharmacokinetic data supports a once-daily oral dosing regimen for CT-996.
Year to date, Roche’s shares gained 0.1% compared to the industry’s 23.4% growth.
Image Source: Zacks Investment Research
Roche forayed into the obesity market when it acquired privately owned Carmot Therapeutics for $2.7 billion. The acquisition added a differentiated incretin portfolio with three candidates — CT-388, CT-996 and CT-868 — to its pipeline.
CT-388 is an investigational dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes. The candidate is currently in phase II. CT-868 is an investigational, once-daily, subcutaneously injected dual GLP-1/GIP receptor agonist, currently in phase II, with the potential to be a first-in-class treatment for glycaemic control as an adjunct to insulin in patients living with type 1 diabetes.
In May 2024, Roche announced positive results from an early-stage study evaluating CT-388. Over 24 weeks, patients who received this once-weekly, subcutaneously-injected drug achieved a mean placebo-adjusted weight loss of 18.8%.
Per Roche, this recently acquired incretin-based portfolio could also be expanded to other indications where incretins play a role, including cardiovascular and kidney diseases.
The obesity market is currently one of the most lucrative spaces in the healthcare sector, dominated by bigwigs like Novo Nordisk (NVO - Free Report) and Eli Lilly (LLY - Free Report) . The stupendous success of Novo Nordisk’s obesity drug Wegovy put the spotlight on the obesity space.
The FDA approved Weogovy in 2021 for chronic weight management in obese or overweight adults. Since the approval, sales of the drug have been rising consistently, driven by increased demand.
Eli Lilly’s Zepbound also witnessed a strong uptake, owing to solid demand.
Given the significant market potential of obesity, other players are striving to grab a share of this pie as well.
Zacks Rank
Roche currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.