Roche’s oral GLP-1 receptor agonist demonstrates significant weight loss in Phase I study.
The global prevalence of obesity has surged dramatically over the past half century, driving a corresponding increase in pharmaceutical development within this therapeutic area. This week, Roche introduced a new treatment option, marking a significant advancement in the management of obesity.
Facts around obesity
The obesity rate in adults has tripled in women and almost quadrupled in men between 1975 to 2023. In a 2022 study 159 million children between age 5 to 19 years are found suffering from obesity. Obesity is a chronic condition resulting from excessive fat deposition due to genetic predisposition or an unbalanced energy intake to expenditure ratio.
Overweight and obesity are a growing global health crisis. The condition is linked to a significant increase in non-communicable diseases, such as coronary heart disease, type 2 diabetes, and cancer. These health issues start early in life and can have long-lasting consequences. Beyond the physical health impacts, obesity also leads to mental health problems, affects education, and carries a heavy economic burden.
Current treatments
Though dietary changes and exercise have been suggested to be most effective against obesity, recent research has presented many medications as treatment options.
One class of medications includes glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide (Wegovy) and liraglutide (Saxenda). These drugs mimic a hormone that regulates appetite and blood sugar, leading to weight loss.
Another option is phentermine-topiramate (Qsymia), which affects brain neurotransmitters to reduce appetite and increase feelings of fullness. Naltrexone-bupropion (Contrave) combines a mood stabilizer with an opioid blocker for weight management. Orlistat (Alli, Xenical) works differently by preventing fat absorption in the intestines.
About CT-996
CT-996 is an oral GLP-1 receptor agonist initially developed by Carmot therapeutics (recently acquired by Roche) to treat both type-2 diabetes and obesity. Glucagon-like peptide-1 receptor agonist are a class of drugs that can help with weight loss by mimicking a hormone in the body that helps control blood sugar and insulin levels and promotes feelings of fullness. CT-996 is a specifically engineered drug designed to selectively activate the GLP-1 receptor. By primarily stimulating cAMP signaling while minimizing unwanted beta-arrestin activity, CT-996 is expected to promote significant weight loss.
Image: CT-996 shows promising result in phase-1 trial
Clinical Studies, Efficacy and and Side Effects
The phase-1 trial of CT-996 was a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study. The study was done in participants suffering from Overweight/Obese and in patients suffering from Type 2 Diabetes Mellitus. The study has focused on the two endpoints, the tolerability of CT-996 and pharmacokinetics assessment along with its effect on body weight and glucose homeostasis.
The first part of the trial was conducted in 40 participants with overweight or obesity where they were administrated with a single ascending dose of the molecule. The second part was done in 25 participants without type 2 diabetes. It was a multiple ascending dose in three sequential cohorts, which will be followed by the third part of the trial as a multiple ascending dose study in two sequential cohorts of 30 participants with obesity and type 2 diabetes.
The result of the phase 1 trial shows promising results. CT-996 was well tolerated, with mostly mild or moderate side effects such as gastrointestinal-related discomfort but did not provide any evidence to discontinue the study.
Future of the battle against Obesity
The promising result from phase 1 trial pushes the study to its second phase, optimist to join the fight alongside promising drugs such as Zepbound and Wegovy. The potential for CT-996 to serve as a maintenance therapy following weight loss induced by injectables further underscores its potential impact on patient care. With the substantial burden of obesity and type 2 diabetes on global health, the development of effective oral treatment options like CT-996 is hopeful and crucial.
Dr. Avraneel Paul, Ph.D.
Sources:
- https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
- https://clinicaltrials.gov/study/NCT05814107?cond=obesity&term=CT-996%20&checkSpell=&rank=1
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