Eli Lilly presents phase 2b trial data of dual GIP, GLP-1 receptor agonist

Results from a phase 2b clinical trial of Eli Lilly’s dual GIP and GLP-1 receptor agonist showed strong and clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes. The six-month data, showing average HbA1c reductions of up to 2.4 percentage points and an average weight reduction up to 11.3 kg ,were presented at the 54th annual meeting of the European Association for the Study of Diabetes and simultaneously published in The Lancet. The weekly dual glucose-dependent insulinotropic polypeptide, or GIP, and GLP-1 receptor agonist integrates the action of both incretins into a single novel molecule, aiming to build upon the clinical benefits seen with a selective GLP-1 RA. Two statistical approaches were used to evaluate the efficacy of four doses of GIP/GLP-1 RA compared to placebo and dulaglutide 1.5 mg in people with type 2 diabetes. The first was a dose response model evaluating the effect regardless of discontinuation of treatment and use of rescue medication. An additional analysis identified the effect while on treatment and without use of rescue medication. At 26 weeks, the primary analysis showed a robust dose response compared to placebo throughout the entire dose range of GIP/GLP-1 RA included in the study. The safety profile of GIP/GLP-1 RA was similar to the GLP-1 RA class. The most commonly reported side effects were gastrointestinal-related, and dose-dependent. These events included nausea, diarrhea and vomiting which were mild to moderate and generally temporary, most often occurring during the titration period. Dulaglutide 1.5 mg had a similar side effect profile to previous studies. No participants in any of the treatment groups experienced severe hypoglycemia. A further study examining an optimal titration schedule to help manage GI side effects was conducted and will be presented next year. The safety and efficacy of Lilly’s GIP/GLP-1 RA are being studied further in a large phase 3 clinical program that will be referred to as the SURPASS program. Phase 3 studies for type 2 diabetes are expected to begin no later than early 2019 and complete in late 2021. Lilly is evaluating next steps in the study of GIP/GLP-1 RA for obesity and other conditions.

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