Tern’s oral GLP-1 achieves 5% weight reduction within one month at the highest dose

Terns Pharmaceuticals’ decision to move away from the liver disease field may turn out to be beneficial since early phase 1 data suggests that another of its candidates – TERN-601 – may also be effective in reducing weight.
To assess the acute pharmacodynamics effect of TERN-601 in healthy overweight/obese adult volunteers a randomized, double-blind, placebo-controlled cross-over study was conducted in 36 overweight or obese subjects for a total duration of 28 days. The highest dose, 740 mg per day, was found to have a mean weight loss of just under 5%, while the participants on the 500 mg and 240 mg doses had just under 4% and 2% weight loss respectively.

The drug was safe and without significant intolerance at all dosage levels; none of the treatment was stopped, reduced, or interrupted by side effects. Overall, over 95% of adverse effects (AE) due to treatment were assessed as mild in severity; of the nine patients in the highest dose group, six developed moderate, or grade 2 AEs. There were no serious adverse effects (grade 3 or higher) reported by any of the participants in the study.
The side effects were mainly gastrointestinal, which is common to the class of drugs known as GLP-1 receptor agonists. However, Terns pointed out that there were no alterations in the liver enzymes, in the vital signs, and in the participants’ electrocardiograms that could be categorized as clinically significant.
Terns is moving into the market for obesity treatment, which is currently dominated by Novo Nordisk and Eli Lilly’s injectable GLP-1 drugs, WeGovy and Zepbound. Novo treatment provides the average weight loss of about 15% over a period of 68 weeks while Terns study is limited to 28 Days. Nevertheless, Terns’ results are similar to Viking Therapeutics, which in March showed that 57% of patients taking the oral dual GLP-1 and GIP receptor agonist lost a minimum of 5% of their body weight.
Terns also pointed out that TERN-601 had “low solubility and high gut permeability” which could be a positive sign compared to other oral GLP-1R agonists as it may promote longer drug absorption in the gut that may reach the hunger regulatory center of the brain. Moreover, there is the PK profile of TERN-601 which demonstrates relatively low free concentration in the serum and has a virtually flat PK curve, which may explain the drug’s relative tolerability at higher doses.

Moving forward, Terns aims to move TERN-601 to phase 2 control in the following year, to demonstrate other applications of the same including the treatment of obesity individually and with other pipeline drugs for instance TERN-501 or TERN-800.

The post Tern’s oral GLP-1 achieves 5% weight reduction within one month at the highest dose appeared first on LifeSci Voice.