Drugs

Roche Reports Positive Phase 2 Data for Obesity Drug

Roche says its experimental dual GLP-1/GIP receptor agonist CT-388 delivered substantial and statistically significant weight loss in a Phase 2 study of people living with obesity, supporting the drug’s advancement into late-stage development. Topline results from the CT388-103 trial showed that once-weekly subcutaneous injections of CT-388 produced a placebo-adjusted weight loss of 22.5% at 48 weeks at the highest dose tested (24 mg), without evidence of a weight loss plateau.

CT-388’s Phase 2 efficacy appears competitive with leading dual-agonist obesity drugs on the market (e.g., Lilly’s Zepbound (tirzepatide)) and stronger than typical results for semaglutide (Novo Nordisk’s Wegovy), but next-generation agents like Lilly’s retatrutide may exceed these benchmarks in extended trials.

More than half (54%) of participants in the study receiving CT-388’s 24 mg dose achieved resolution of obesity, compared with 13% in the placebo group, according to the company. Nearly all treated patients (95.7%) achieved at least 5% weight loss, while 47.8% lost 20% or more of their body weight and 26.1% lost at least 30%. Among participants who were prediabetic at baseline, 73% of those treated with CT-388 at the highest dose achieved normal blood glucose levels by week 48, compared with 7.5% in the placebo arm, it says.

Roche says the treatment was generally well tolerated, with gastrointestinal side effects that were mostly mild to moderate and consistent with the known safety profile of incretin-based therapies. Discontinuation due to adverse events was low, occurring in 5.9% of participants across CT-388 treatment arms, compared with 1.3% in the placebo group. No new or unexpected safety signals were reported.

Roche expects to initiate its Phase 3 obesity program, known as Enith1 and Enith2, later this quarter.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome