ISSUE NO. 5 — Metabolic Disorders (Obesity, Diabetes, NAFLD/NASH) — Updated 2021

Metabolic disorders are conditions that disrupt normal metabolism and the process of converting food to energy at the cellular level. They affect the ability of the cell to perform critical biochemical reactions that involve the processing or transport of proteins (amino acids), carbohydrates (sugars and starches), or lipids (fatty acids). Metabolic disorders can take many forms, with obesity and diabetes being the most common.

The worldwide prevalence of obesity has nearly tripled between 1975 and 2022. Once considered a high-income country problem, obesity is  on the rise even in low- and middle-income countries.

In Issue 5 of The Altascientist, we investigate the challenges of metabolic disorders, with insights from Altasciences’ clinical and preclinical experts, as well as:

• Frequently asked questions about clinical trials for metabolic disorders
• An Altasciences case study
• A hidden threat: nonalcoholic fatty liver disease (NAFLD)
• Altasciences’ end-to-end patient recruitment process and patient access for NASH studies

Obesity, Diabetes, and Metabolic Dysfunction

As obesity continues to rise globally, the risk of developing associated metabolic disorders, including type 2 diabetes, has escalated.

Several epidemiologic studies reveal a direct link between the escalation of obesity and diabetes. The pathophysiology connecting the two metabolic disorders is mainly attributed to two factors: insulin resistance and insulin deficiency. Research shows that if you are obese, your chances of developing type 2 diabetes are 80 times greater than a person whose body mass index (BMI) is within a normal range (under 25).

Type 2 diabetes is a dysfunction in the way the body metabolizes glucose, causing it to rely on alternative energy sources from tissues, muscles, and organs. Individuals suffering from the disease are either resistant to insulin or do not produce enough of it to maintain healthy blood glucose levels.

Nonalcoholic Fatty Liver Disease (NAFLD)

Much like obesity and diabetes, nonalcoholic fatty liver disease (NAFLD) is a global epidemic, with prevalence rates reaching 25% to 30%. NAFLD can be divided into the milder form, nonalcoholic fatty liver (NAFL), and the more aggressive form, nonalcoholic steatohepatitis (NASH).  It is characterized by different levels of hepatic steatosis (fat deposition), inflammation (in NASH), and fibrosis.

Despite the growing prevalence of NAFLD/NASH, treatment options remain extremely limited. A large number of pharmaceutical companies have started to conduct clinical studies to develop treatments for NASH, but recruiting patients for these types of studies is particularly challenging as this disease does not present with clear symptoms, and the majority of patients do not know they have it or are not diagnosed until significant damage to the liver has occurred.

“One of our ultimate goals is to develop approaches for better diagnosis and management of chronic liver disease, which is currently an increasing worldwide concern, and demands early-phase trials that require specific imaging and biomarker services. We are continuously expanding Altasciences’ therapeutic offerings in gastrointestinal disease-specific studies, particularly those intended to investigate the efficacy of drugs in patients with NASH.”

Dr. Gaetano Morelli, MD, Executive Vice President Medical Affairs,
Chief Medical Officer

Altasciences saw the developing need for patients with NASH and proactively built a database of patients suffering from the disease using an IRB-approved protocol we sponsored ourselves. Since NASH patients are often underdiagnosed, Dr. Gaetano Morelli used his expertise in NASH to build a campaign based on a set of criteria the patients will recognize as applicable to them. 

Altasciences’ Expertise in Metabolic Disorders

Our ability to effectively recruit patients, our clinical operational experience, and our robust list of validated bioanalytical assays—including exenatide, glucagon, insulin glargine, M1, M2, insulin aspart, and metformin—provide the perfect solution for organizations studying obesity and developing treatments for metabolic disorders.

“We have conducted many different types of studies in these patient populations, from first-in-human (FIH), single ascending dose (SAD) to proof-of-concept (POC) studies. The focus of the studies ranges from glucose tolerance to pharmacokinetics, comparing obese subjects to those with normal weights.”

Ingrid Holmes, Vice President, Global Clinical Operations

Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.