The first data are encouraging. And we arrived at phase 3, the last before the marketing of the drug. If everything is confirmed by further studies, we will be faced with a new revolution, since we are talking about the First drug administering orallynot peptide and agonist of the GLP-1 receptor (Glucagon-like Peptide-1 receptor agonist), to have successfully completed this level of progress in the research. But how it works ORFORGLIPRON? And how can it be used, if in the future these data will be confirmed and will be available for patients?
Because it is important to act on the GLP-1
The abbreviation GLP-1 is well known. In fact, this represents a target for drugs already present in clinical use. We are talking about a detail hormone Which, on the basis of the combined action that highlights the link between intestine and brain, naturally produces after meals. When this phenomenon occurs, the hormone in practice function as a natural control system (not the only one of course) of the glucose. That is, it stimulates insulin secretion and inhibits the secretion of glucagon by the pancreas. In this sense the Glucagon-like Peptide 1an English term that expresses this hormonal component, becomes part of the so -called income.
But be careful: the GLP-1 does not limit its activity to the production of insulin by the pancreas, with consequent better use of sugars introduced with food. In fact, it also promotes the slowdown of gastric emptying. Because of this you feel more “full” And the sense of satiety increases, reducing appetite. Not only that. Together with another “ingredient” of the metabolism, the investigating judge also acts on brain. In practice at the level of the central nervous system it changes the nervous activity of neurons that have as their task the Hunger and satiety control. And this also contributes to inducing the sense of fullness, with a substantial reduction in the quantity of foods that is introduced.
How ORforglipron works and what is expected
ORforglipron is a Experimental druga small (non-peptide) oral agonist of the GLP-1 receptor oral, which does not require fasting or food restrictions. Discovered by Chugai Pharmaceutical Co., Ltd. and licensed in Lilly in 2018, is Currently in phase 3 For the treatment of type 2 diabetes and weight management in adults with obesity or overweight with at least a correlated comorbilities. It is also in experimentation for the treatment ofObstructive apnea of sleep and hypertension in obese patients. In recent days Eli Lilly has announced today the results of phase 3 of the Achieve-1 studio, aimed at evaluating the safety and efficacy of Orforglipron compared to placebo in adults with type 2 diabetes not adequately controlled with diet and exercise. ORforglipron is precisely The first non -peptide oral drug GLP-1 RA receptor agonist (Glucagon-like Peptide-1 receptor agonist), successfully completed a phase 3 experimentation.
“Achieve-1 is the first of seven phase 3 studies that examine the safety and efficacy of Orforglipron in people with diabetes and obesity. We are pleased to ascertain that our latest drug-based drug meets our expectations in terms of safety and tolerability, glucose control and weight loss, and we look forward to reading further data during the year. If approved, it could be easily produced and on a large scale to be used by people from all over the world “
It is the comment of David A. Ricks, president and CEO of Lilly.
What are the results in the clinic
In the first clinical trial of the Achieve program, ORforglipron reached the primary objective of reducing glycated hemoglobin (A1C) compared to placebo after 40 weeks, with an average reduction between 1.3% and 1.6% with a starting point of 8% according to estimates of effectiveness.
Among the secondary endpoints, the participants treated with ORforglipron lost about 7.2 kilos (at the highest dose) and over 65% reached a value of A1C ≤ 6.5%, lower than the threshold established by the American Diabetes Association (Ada) for diagnosis of diabetes. In all results according to estimates of the therapeutic regime, the dosages of Orforglipron determined statistically significant reductions of the 11C. Secondary endpoints on body weight for 12 mg and 36 mg dosages also showed significant reductions. The overall security profile of Orforglipron in the Achieve-1 studio was consistent with that of the GLP-1 class.
Geladverse events More common have been gastrointestinal type, with mainly mild or moderate intensity. For participants treated respectively with 3 mg, 12 mg and 36 mg, the most common adverse effects were diarrhea (19%, 21%and 26%) compared to 9%with placebo, nausea (13%, 18%and 16%) compared to 2%with placebo, dyspepsia (10%, 20%and 15%) compared to 7%with placebo, constipation (8%, 17%) compared to 4%) placebo and vomiting (5%, 7% and 14%) compared to 1% with placebo.
The overall treatment rates of treatment due to adverse events were 6% (3 mg), 4% (12 mg) and 8% (36 mg) per oforglipron compared to 1% with placebo. Not signs of liver toxicity have been observed.
