Pfizer Discontinues Development of Investigational Oral GLP-1 for Weight Management
One asymptomatic patient did experience drug-induced liver injury that was resolved after discontinuation of danuglipron.
Pfizer discontinued the development of danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist previously investigated for chronic weight management. Data from the clinical development program will be presented at a scientific meeting and published in a peer-reviewed journal in the future.1
One asymptomatic patient did experience drug-induced liver injury that was resolved after discontinuation of danuglipron. | Image Credit: NCST Studio - stock.adobe.com
“Cardiovascular and metabolic diseases, including obesity, remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity programs,” Chris Boshoff, MD, PhD, chief scientific officer and president of Research and Development at Pfizer, said in a news release.1 “While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients.”
After a review of the data, the company decided to discontinue development of the molecule. In 2 dose-optimization studies, investigators found that the results did meet the key pharmacokinetic objectives and confirmed a formulation and dose for a potential phase 3 trial. The overall findings showed elevated liver enzymes, but that was in line with approved GLP-1 medications. However, one asymptomatic patient did experience drug-induced liver injury that was resolved after discontinuation of danuglipron.1
In the first study (NCT06567327), investigators aimed to determine how the medication was absorbed in the blood, if the medication changed how the body processed atorvastatin and rosuvastatin, and establish the safety and efficacy of the drug. There were 4 cohorts, with one lasting 23 weeks, one lasting 22 weeks, one lasting 21 weeks, and the last lasting about 20 weeks, according to the clinical trial information.2
The primary end points included the steady-state area under the concentration-time curve from zero to 24 hours (AUC24), steady-state maximum observed concentration (Cmax), steady-state time to reach maximum observed concentration (Tmax), area under the concentration-time curve from zero to infinite time as data permitted for atorvastatin and rosuvastatin, and area under the concentration-time curve from time zero to the time of the last quantifiable concentration for atorvastatin and rosuvastatin. Secondary endpoints included treatment-emergent adverse events (TEAEs), clinically significant laboratory abnormalities, vital sign abnormalities, and change from baseline in body weight.2
In the second study (NCT06568731), investigators had similar aims, including how the medication is absorbed in the blood as well as the safety and tolerability. The study lasted approximately 14 weeks. The primary end point included AUC24, Cmax, and Tmax. The secondary end points included TEAEs, clinically significant laboratory abnormalities, viral sign abnormalities, and change from baseline in body weight, according to the clinical trial information.3
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