Roche Reports Upbeat Efficacy Data From Phase II Obesity Study

Roche Holding AG RHHBY announced positive top-line data from a mid-stage study of its investigational candidate, CT-388, being developed for the treatment of obesity. CT-388 is a once-weekly injectable dual GLP-1/GIP RA, designed to curb appetite and improve blood-sugar control by targeting key metabolic pathways.Roche’s phase II dose-finding study evaluated CT-388’s efficacy and safety across multiple dose levels in 469 adults with obesity or overweight with at least one weight-related comorbidity without type II diabetes (T2D), testing up to a 24 mg dose. The primary endpoint of the study was the percentage change in body weight from baseline to week 48.RHHBY’s Phase II Obesity Data in DetailPer the data readout from Roche’s phase II study, once-weekly CT-388 delivered robust and clinically meaningful weight loss in adults with obesity or overweight. At the highest tested dose of 24 mg, the drug achieved a placebo-adjusted weight reduction of 22.5% at 48 weeks under the efficacy estimand, with no evidence of a weight-loss plateau. Results also demonstrated a clear dose-response relationship, reinforcing the strength of the underlying efficacy signal.Under the treatment regimen estimand, CT-388 produced a placebo-adjusted weight loss of 18.3% at week 48, with strong statistical significance. The depth of response was notable, with nearly all patients (95.7%) on the 24 mg dose achieving at least 5% weight loss, while a substantial proportion reached higher thresholds, including close to half (47.8%) achieving 20% or more and 26.1% of patients exceeding 30% weight loss.In the past six months, Roche’s shares have soared 40.6% compared with the industry’s 26.5% growth.Image Source: Zacks Investment ResearchBeyond weight reduction, CT-388 showed favorable metabolic effects. Among participants who were pre-diabetic at baseline, 73% achieved normal blood glucose levels by week 48 on the 24 mg dose, compared with 7.5% in the placebo group. This highlights the therapy’s potential to address both obesity and related metabolic dysfunction.The candidate's safety profile was consistent with expectations for incretin-based therapies. Most gastrointestinal adverse events were mild to moderate in severity. Treatment discontinuation due to adverse events remained low at 5.9% across CT-388 arms, supporting tolerability at higher dose levels. Roche expects to share detailed results from the study at an upcoming medical conference.Following these data, CT-388 has been positioned as a fast-track asset within Roche’s pipeline, with phase III obesity studies (Enith1 and Enith2) expected to begin this quarter. An additional phase II study of CT-388 is ongoing in obese/overweight patients with T2D. RHHBY is also evaluating the candidate as a potential combination partner within its broader obesity pipeline, including petrelintide.Per Roche, obesity represents the leading global risk factor for chronic disease. By 2035, more than four billion people — over half of the world’s population — are expected to be overweight or obese, a trend spanning nearly all regions. This growth reflects a complex interplay of biological, behavioral, environmental and socioeconomic factors, significantly increasing healthcare burdens through higher rates of comorbidities and diminished quality of life.Roche Holding AG Price and Consensus Roche Holding AG price-consensus-chart | Roche Holding AG QuoteRHHBY’s Peers in the Obesity SpaceEli Lilly LLY and Novo Nordisk NVO presently dominate the obesity market. LLY markets its tirzepatide-based (dual GLP-1/GIP RA) injections, Mounjaro and Zepbound, which compete directly with NVO’s semaglutide-based (GLP-1 RA) injections, Ozempic and Wegovy, for T2D and obesity, respectively. Both companies generate a substantial portion of revenues from their respective cardiometabolic drugs.Novo Nordisk secured the long-awaited FDA approval for its oral Wegovy pill to treat obesity and reduce cardiovascular risk in late December, followed by its commercial launch in early January. This marked a major milestone, making Wegovy the first GLP-1 RA available in an oral form for weight management. Compared to injectable formulations, the pill offers a far more convenient administration option. Eli Lilly’s regulatory application seeking the approval of its oral GLP-1 pill, orforglipron, for obesity is currently under review by the FDA.The obesity space has garnered much of the spotlight over the past year due to the sizeable and still underpenetrated market opportunity. Smaller biotech firms, like Viking Therapeutics VKTX, are also advancing GLP-1–based therapies to challenge the incumbents. Viking Therapeutics is developing its dual GIP/GLP-1 RA, VK2735, both as oral and subcutaneous formulations for the treatment of obesity. Last year, VKTX started two late-stage studies evaluating the subcutaneous formulation of VK2735. While one of these studies completed enrolment in November 2025 at a rapid pace, Viking Therapeutics expects to complete enrolment in the other study by the end of this quarter.RHHBY’s Zacks RankRoche currently carries a Zacks Rank #3 (Hold). 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(VKTX): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks