Obesity
Conditions
Brief summary
The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.
Interventions
DRUGRAY1225
RAY1225 will be administered SC
DRUGPlacebo
Placebo will be administered SC.
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Body Weight at Week 52 | Baseline and Week 52 |
| Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52 | Baseline and Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Waist Circumference at Week 52 | Baseline and Week 52 |
Countries
China
Contacts
Primary ContactJi, Doctor
Outcome results
None listed