← Trials/Trial dossier/NCT06254261
A Study of RAY1225 in Participants With Obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
Lead sponsor
Asset
RAY1225
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
1
Enrollment
270
estimated
Study population
Obesity / overweight
Key I/E criteria
•BMI ≥28•HbA1c 5.7-6.5%
Primary endpoint
•Body Weight
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 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%;
2. 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
1. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
2. with a history of diabetes or hypoglycemia;
3. 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.
4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
5. allergic constitution;
6. not suitable for subcutaneous injection.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Weight & body composition
5 endpointsChange From Baseline in Body Weight
Time frame:Baseline,Week26
change from baseline, improvement
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame:Baseline,Week26
threshold achievement, improvement
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame:Baseline,Week26
threshold achievement, improvement
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame:Baseline,Week26
threshold achievement, improvement
Change from Baseline in Waist Circumference in Centimeter
Time frame:Baseline,Week26
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.