CT-388 weekly injection led to 22.5% placebo-adjusted weight loss at 48 weeks with no plateau at the highest 24 mg dose.
Genentech, part of the Roche Group, announced positive topline results from its Phase II CT388-103 trial evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist for the treatment of obesity. The study found that once-weekly subcutaneous injections of CT-388, titrated up to 24 mg, led to significant placebo-adjusted weight loss of 22.5 percent at 48 weeks without reaching a plateau. A clear dose-response effect was observed across the study. For the treatment-regimen analysis, participants experienced an 18.3 percent placebo-adjusted weight loss with high statistical significance. At the highest dose, 95.7 percent of participants achieved at least 5 percent weight loss, 87 percent achieved 10 percent, 47.8 percent achieved 20 percent, and 26.1 percent achieved 30 percent or more. Additionally, 73 percent of participants who were pre-diabetic at baseline reached normal blood glucose levels by week 48 compared to just 7.5 percent in the placebo group.
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The treatment was generally well-tolerated with most adverse events related to gastrointestinal effects being mild to moderate, consistent with the incretin drug class. Discontinuation due to adverse events was low at 5.9 percent for CT-388 arms compared to 1.3 percent for placebo. The full study results are expected to be presented at an upcoming medical congress.
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Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech, stated that the robust weight loss and favorable safety profile reinforce confidence in advancing CT-388 into Phase III trials. He noted that the data highlight the potential for CT-388 to become a transformative therapy for people living with obesity.
Obesity remains a leading global risk factor for chronic disease. By 2035, over four billion people worldwide are projected to have excess weight or obesity, driven by genetic, biological, behavioral, and socioeconomic factors. This growing prevalence increases the strain on healthcare systems due to associated comorbidities and reduced quality of life.
CT-388 has been designated a fast-track asset within Genentech to accelerate clinical development and make the therapy available to patients as quickly as possible. The compound is currently being tested in an additional Phase II trial, CT388-104, which evaluates safety, efficacy, and tolerability in people with obesity or overweight with type 2 diabetes. Phase III trials, Enith1 and Enith2, are expected to begin this quarter. Beyond its potential as a standalone therapy, CT-388 may also serve as a combination asset within Genentech’s broader obesity pipeline.
The CT388-103 study enrolled 469 adults with obesity or overweight and at least one weight-related comorbidity without type 2 diabetes. The trial evaluated five dosing cohorts with titration up to 24 mg, using percent change in body weight from baseline to week 48 as the primary endpoint.
CT-388 is designed as a once-weekly injectable dual GLP-1/GIP receptor agonist aimed at reducing appetite and regulating blood sugar through potent activation of both receptors while minimizing receptor internalization. This mechanism supports prolonged pharmacological activity and targeted metabolic benefits for people living with obesity and related conditions.
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