US EditionRoche's Obesity Drug Helps Almost 87% People Lose At Least 10% Weight - Roche Holding (OTC:RHHBY)
CT-388 showed a strong dose-response with 95.7% of participants losing over 5% body weight and 26.1% losing over 30% at 48 weeks, with mostly mild gastrointestinal side effects.
- On Tuesday, Roche Holdings AG released CT388-103 topline results showing more than 87% of CT-388-treated participants achieved over 10% weight loss at week 48.
- The 48-patient CT388-103 Phase 2 trial evaluated CT-388 as a once-weekly subcutaneous dual GLP-1/GIP receptor agonist across five dosing cohorts with up-titration, in adults with obesity or overweight and at least one weight-related comorbidity, Roche said.
- Placebo-Adjusted measures showed significant weight loss with treatment-regimen and efficacy estimands recording 18.3% and 22.5% reductions, while responder thresholds at week 48 included 95.7% >5%, 47.8% >20%, and 26.1% >30%.
- Safety readouts indicated tolerability consistent with the drug class, with mostly mild-to-moderate gastrointestinal-related adverse events and treatment discontinuation rates of 5.9% in CT-388 arms versus 1.3% placebo.
- Roche designated CT-388 as a fast-track asset and expects Phase III programmes Enith1 and Enith2 to start this quarter, exploring petrelintide combination plans after the Carmot Therapeutics acquisition .
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The company paved the way in the fight against obesity drugs with robust results from the mid-phase clinical trial of CT-388 and is moving towards the start of its late-phase study.
Roche moves obesity drug to pivotal trials after mid-stage success
Roche plans to launch Phase 3 studies of its leading obesity candidate this quarter after reporting Tuesday that the drug led to significant weight loss in a mid-stage trial. The drug, known as CT-388, led to a placebo-adjusted weight loss of 18.3% after 48 weeks in the Phase 2 trial at the highest dose tested of 24 milligrams, the Swiss pharma said. Roche said that patients were still losing weight at the end of the study period. Just under 6%…
Roche's Obesity Drug Helps Almost 87% People Lose At Least 10% Weight - Roche Holding (OTC:RHHBY)
Roche Holdings AG (OTC:RHHBY) on Tuesday released topline results from the CT388-103 Phase 2 trial of CT-388 for obesity. CT-388 is an investigational once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity, type 2 diabetes, and other obesity-related comorbidities. Trial Data The 469-patient trial was designed to evaluate the efficacy and safety of CT-388 at low, middle, and high doses. I…
[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity
A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p 54% of participants on the 24 mg dose achieved...
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