A novel dual glucagon-like peptide and glucagon receptor agonist SAR425899: Results of randomized, placebo-controlled first-in-human and first-in-patient trials
| Autor: | Lenore Teichert, Frank Wagner, Michael Wagner, Martin Bossart, Youssef Hijazi, Stefanie Keil, J. Tillner, Maximilian G. Posch, Torsten Haack, Philip J. Larsen, Christine Einig |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Blood Glucose Male Agonist medicine.medical_specialty Adolescent medicine.drug_class Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism Type 2 diabetes 030204 cardiovascular system & hematology Overweight Placebo Gastroenterology Glucagon Glucagon-Like Peptide-1 Receptor Placebos Young Adult 03 medical and health sciences 0302 clinical medicine Endocrinology Weight loss Internal medicine Receptors Glucagon Internal Medicine Humans Hypoglycemic Agents Medicine Obesity Adverse effect business.industry Body Weight nutritional and metabolic diseases Middle Aged medicine.disease Lipids Diabetes Mellitus Type 2 Female medicine.symptom business Body mass index |
| Zdroj: | Diabetes, Obesity and Metabolism. 21:120-128 |
| ISSN: | 1462-8902 |
| Popis: | AIMS To evaluate the safety, pharmacokinetics and pharmacodynamics of SAR425899, a novel polypeptide, active as an agonist at both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCR), in healthy volunteers and in overweight/obese patients with type 2 diabetes (T2D). METHODS Subcutaneous administrations of SAR425899 were tested in two randomized, placebo-controlled, double-blind clinical trials. In the first trial, healthy overweight volunteers (body mass index [BMI] 25-30 kg/m2 ; n = 32) received single-ascending doses (0.01-0.1 mg) of SAR425899 or placebo. In the second, a multiple-ascending-dose trial (NCT02411825), healthy normal- to overweight volunteers (BMI 20-30 kg/m2 ; n = 40) and overweight/obese patients with T2D (BMI 28-42 kg/m2 ; n = 36) received daily doses of SAR425899 or placebo over 21 or 28 days, respectively. RESULTS The most frequently reported adverse events were gastrointestinal; gastrointestinal side effects were less pronounced in patients with T2D compared with healthy volunteers. SAR425899 significantly reduced levels of fasting plasma glucose (P |
| Databáze: | OpenAIRE |
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