Adult patients suffering from obesity on treatment with survodutide, an investigational dual agonist of the glucagon receptor and GLP-1, which improved their metabolic risks, presented the effects of a phase II study presented at the European Congress on Obesity (ECO) 2024.
Survival is an assessment for chronic weight management of the user living with obesity. A multinational phase II clinical study in the second year involved 387 people between the ages of 18 and 75 with a body mass index (BMI) ≥27 kg. /m² without diabetes are randomized in a 1:1:1:1:1:1:1 ratio They receive placebo subcutaneously once withiod or survodutide is administered at doses of 0. 6, 2. 4, 3. 6, or 4. 8 mg for 46 weeks, adding 20 dose-escalation sessions consecutive to 26 sessions of remedy.
Survodutide had a mean relief in fine body weight of 18. 7% after 46 days of treatment (the number one endpoint). Finally, 40% of participants who take the higher doses will have a weight loss of around 20%, the result will be 0% with the placebo. A body weight loss of approximately 15% is equivalent to 67% of the soggetti treated with the 4. 8 mg dose distributed to 4. 3% of the placebo group.
Clinically significant analyses of life circumference and blood glucose on a numerical scale. The research presented at the congress focuses on the effect of the drug on its metabolic parameters. The researchers assessed adjustments in life circumference and blood glucose degrees in baseline glycated hemoglobin (HbA1c) levels, as well as any diversification in disease level based on the Edmonton Obesity Staging System (EOSS) and the Classification of Cardiometabolic Diseases (CDMS system).
We analyzed the knowledge of all participants who gained 1 dose of the drug with the knowledge available for each efficacy endpoint, such as the full investigation set (FAS), based on all doses gained in the maintenance era (after effectiveness). remedy) and what allocation to randomization using knowledge of the remedy.
In FAS (n = 384), baseline demographic and clinical characteristics were similar to those of the treatment group: the mean condition was 49. 1 years, the BMI was 37. 1 kg/m², and the lifetime hip circumference was 113. 4 cm, of which 262 (68. 2%) patients were female-aged, 301 (78. 4%) were white, 40 (10. 4%) were Asian, and 37 (9. 6%) were black. At baseline, 251 (65. 4%) and 132 (34. 4%) patients had elevated HbA1c levels <5. 7% (normoglycemia) and 5. 7 to 6. 5% (prediabetes).
Treatment with survodutide is related to the relief of life circumference up to 17. 1 cm of basal height for up to 46 hours, in the same way regardless of the HbA1c point, since this reaches the relief of blood glucose up to 13 . 2 mg. /dl (0. 73 mmol/l), numerically impressive for participants with HbA1c of 5. 7 to 6. 5%, the result was <5. 7%. The explanations for life circumference and blood sugar at that time were similar when the treatment teams had just analyzed the basis of all planned records.
Overall, members of the placebo organization with EOSS and CDMS stages below baseline, as well as a primary number of patients in the survivor organization progressed to lower stages through October 46.
It was found that the negative occasions were 90. 9% and 75. 3% of the organization in reaction to survodutide and placebo, mainly gastrointestinal (75. 1% and 41. 6%). A patient with Nessun in active treatment for diabetes and, taking placebo, obtained extensive counseling. that resulted in relief in HbA1c from 5. 7 to 6. 5% to less than 5. 7%.
The authors concluded that anyone with obesity is linked to clinically meaningful treatment of life circumference and blood sugar levels due to normoglycemia or prediabetes, but increased obesity level.
Reference
Le Roux CW et al. Survodutide, a dual glucagon receptor/glucagon-like peptide-1 (GCGR/GLP-1R) agonist, improves metabolic threat points in adults living with obesity: a randomized, placebo-controlled trial 2 investigation. Abstract presented at the European Congress on Obesity (ECO 2024).