Clinical trial

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

Recruiting now · Phase 3 · 1 countries · Registry ID NCT06893016

Recruiting nowPhase 3Interventional

What this study is about

The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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.

Treatments and study arms

RAY1225

Drug

RAY1225 will be administered SC

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

Percent Change From Baseline in Body Weight at Week 52Baseline and Week 52
Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52Baseline and Week 52

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Peking University People's Hospital🇨🇳 Beijing, China
Ji, DoctorContact