A Study of RAY1225 in Participants With Obesity
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: 18 years — 70 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 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
Overview
The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.
Interventions
- Drug RAY1225
Administered SC - Drug Placebo
Placebo
Primary outcome measures
- Change From Baseline in Body Weight [Time frame: Baseline,Week26]
Secondary outcome measures (4)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Time frame: Baseline,Week26]
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Time frame: Baseline,Week26]
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Time frame: Baseline,Week26]
- Change from Baseline in Waist Circumference in Centimeter [Time frame: Baseline,Week26]
Eligibility criteria
Inclusion criteria
- Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and < 6.5%;
- Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
Exclusion criteria
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- with a history of diabetes or hypoglycemia;
- Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
- allergic constitution;
- not suitable for subcutaneous injection.
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 — Beijingcun
Identifiers
NCT: NCT06254261 · RAY1225-23-02