Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial
Abstract
Background: Elecoglipron is an oral, small molecule glucagon-like peptide (GLP)-1 receptor agonist currently in development for the management of type 2 diabetes. Elecoglipron is orally administered once daily with no food or fluid restrictions. SOLSTICE, a phase 2b study, evaluated the efficacy, safety, and tolerability of elecoglipron versus placebo in participants with type 2 diabetes.
Methods: This phase 2b, randomised, double-blind, placebo-controlled trial was conducted in medical research centres and hospitals across nine countries, Canada, Germany, Hungary, Japan, Poland, Slovakia, Spain, the UK, and the USA. Sites were selected based on their capacity to fulfil protocol requirement, including, but not limited to, regulatory and ethics approvals, appropriate infrastructure and personnel, and access to the target patient population. Participants aged 18 years and older with a BMI of 23 kg/m2 or higher and type 2 diabetes (glycated haemoglobin [HbA1c] ≥7·0% to ≤10·5%, ≥6·5% to ≤10·5% in the USA) managed with diet and exercise alone or monotherapy with metformin or an SGLT2 inhibitor were enrolled. Participants were randomly assigned (3:5:3:5:3:3:6:4) via an interactive web response system to elecoglipron as oral once-daily tablets without dose escalation (5, 15, or 25 mg) or three different dose-escalation regimens, to target doses of 50 mg and 75 mg. The daily dose of 50 mg was evaluated using an every 2-week dose-escalation schedule, while 75 mg was assessed with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 404 participants or records.
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