Recruiting NCT06893016
Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RAY1225, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants Who Have Obesity or Are Overweight
Overview
The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.
Interventions
- Drug RAY1225
RAY1225 will be administered SC - Drug Placebo
Placebo will be administered SC.
Primary outcome measures
- Percent Change From Baseline in Body Weight at Week 52 [Time frame: Baseline and Week 52]
- Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52 [Time frame: Baseline and Week 52]
Secondary outcome measures (1)
- Change From Baseline in Waist Circumference at Week 52 [Time frame: Baseline and Week 52]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years.
- 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.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion criteria
- Obesity known to be caused by monogenic mutations, other diseases, or medications.
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
- 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.
- A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.
- Plans to quit smoking during the study period
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06893016 · RAY1225-24-07