Rhythm Pharmaceuticals’ investigational drug relamorelin speeds up the passage of food through the stomach and reduces vomiting in adult patients with diabetic gastroparesis — a condition slowing the movement of the gut. Results from a Phase 2 clinical trial, published in the journal Gastroenterology, also indicated that 28 days of treatment improved other symptoms caused by the condition.
The study, “Relamorelin Reduces Vomiting Frequency and Severity and Accelerates Gastric Emptying in Adults With Diabetic Gastroparesis,” enrolled 204 patients patients with diabetic gastroparesis from 27 clinical centers, of whom 88 percent had type 2 diabetes.
Diabetic gastroparesis, with nausea, vomiting, and bloating caused by a delay of stomach emptying, affects about half of all diabetes patients, and is notoriously difficult to treat.
The investigational drug relamorelin aims to improve the passage of food through the stomach by acting on the hormone ghrelin, involved in regulating hunger.
In the trial, patients were randomized to receive either a placebo or relamorelin, once or twice daily. Neither patients nor clinical staff were aware of which treatment was given to an individual.
Patients receiving the drug two times a day had a shorter gastric emptying time, and vomited on average 60 percent less than patients on the placebo. The drug did not affect other symptoms such as nausea, abdominal pain, or bloating.
However, when looking specifically at the 119 patients who had a more severe condition and vomited at study start, the twice-daily treatment was found to also reduce nausea, stomach pain, bloating, and feelings of being full too early when eating.
The study also explored the safety of the drug, and findings showed that the rates of side effects were similar among patients receiving relamorelin and the placebo. The most common side effects were headache and a worsening diabetes.
However, in an editorial published in the same issue of Gastroenterology, Pankaj Jay Pasricha, from Johns Hopkins University School of Medicine and William Snape, from California Pacific Medical Center, expressed their skepticism of the study.
Noting that the effects, particularly on stomach emptying, were in the mild to moderate range, without affecting the debilitating symptom of nausea, Pasricha and Snape wrote that the trial adds to previously studies demonstrating that “moving the stomach” might not be the best approach to harness the symptoms of diabetic gastroparesis.
Also, the fact that relamorelin — as a trigger of the hormone ghrelin — can affect bodily processes in organs as disparate as the brain, heart, and pancreas, not to mention worsening of diabetes among diabetic patients, makes it a particularly unsuitable candidate for long-term treatment.
