Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called RAY1225 for adults who are overweight or have obesity. The main goal is to see if RAY1225 can help people lose more weight compared to a placebo, which is a treatment that has no active ingredients. This study is not currently recruiting participants, but when it does, it will include adults aged 18 and older who have a body mass index (BMI) of 28 or higher, or a BMI between 24 and 28 with certain weight-related health issues, like high blood pressure or high cholesterol.

To be eligible for this trial, participants need to have tried to lose weight before through diet and exercise but were not successful. However, people with certain medical conditions, such as specific genetic causes of obesity or severe psychiatric issues, cannot participate. Those who join the study will receive either RAY1225 or a placebo and will be monitored for changes in their weight. This trial is important because it aims to find effective treatments for obesity, which can significantly improve health and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years.
• • 2. Body mass index ≥ 28 kg/m2 or ≥24kg/m² to \<28 kg/m2 with at least 1 of the following weight-related comorbidities: a) Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol/L, fasting low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, fasting high-density lipoprotein cholesterol (HDL-C) \<1.04 mmol/L, or the need for at least one lipid-lowering treatment to maintain normal lipid levels; c) Obstructive sleep apnea syndrome; d) Fatty liver; e) Cardiovascular disease; e) Polycystic ovary syndrome.
• • 3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
• Exclusion Criteria:
• • 1. Obesity known to be caused by monogenic mutations, other diseases, or medications.
• • 2. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
• • 3. A history of moderate to severe depression at any time in the past or a score of ≥15 on the PHQ-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders.
• • 4. A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.
• • 5. Plans to quit smoking during the study period
• • 6. Allergic constitution (allergic to multiple medications or foods), or those known to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.