Metabolic Drug Development: A to Z Solutions
In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential.
Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from the initial discovery phase and preclinical studies to clinical trials and beyond.
Here are a few highlights:
- The teams at our four preclinical sites are proficient in obesity and metabolic models, and both GLP and non-GLP studies in rodents, dogs, minipigs, and NHPs.
- Our clinical teams have completed over 50 early-stage trials involving anti-diabetic and hypoglycemic agents, such as insulin, GLP-1, SGLT-2, and DPP-4, with 75 type I and type II diabetic patients enrolled in a single-center trial over four weeks.
- Our clinical database includes over 400,000 participants to more quickly qualify for inclusion/exclusion criteria based on pre-existing conditions, demographics, medication use, and BMI.
- Our scientists have developed bioanalytical assays for exenatide, glucagon, insulin glargine (M1, M2), insulin aspart, and metformin.
- We can develop additional assays tailored to your program.
- We’ve conducted numerous pharmacodynamics and immunogenicity assessments, including high-glycemic load challenge/tolerance tests, glucose clamps, insulin-induced hypoglycemic events in type 1 diabetes, and anti-drug antibody evaluations.
- We support data management both at our clinics and at external sites.
- Our pharmacokinetic, pharmacodynamic, and statistical experts support the analysis of drug concentration, biomarker, subjective measure, and immunogenicity data.
- Our medical writers and scientists have designed thousands of studies and are accustomed to preparing clinical protocols and high-quality reports.
Ready to get started? Speak with one of our experts.
You may also be interested in the following resources:
- Webpage: Metabolism and Endocrinology
- The Altascientist: The Many Faces of Metabolic Disorders
- Case Study: Concomitant Administration of Multiple Doses of Cagrilintide With Semaglutide 2·4 mg for Weight Management