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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06254261
Enrollment
270
Registered
2024-02-12
Start date
2024-02-21
Completion date
2025-12-20
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

Administered SC

DRUGPlacebo

Placebo

Sponsors

Guangdong Raynovent Biotech Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Body WeightBaseline,Week26Percent Change from Baseline in Body Weight

Secondary

MeasureTime frame
Percentage of Participants Who Achieve ≥10% Body Weight ReductionBaseline,Week26
Percentage of Participants Who Achieve ≥15% Body Weight ReductionBaseline,Week26
Percentage of Participants Who Achieve ≥5% Body Weight ReductionBaseline,Week26
Change from Baseline in Waist Circumference in CentimeterBaseline,Week26

Countries

China

Contacts

Primary ContactJI, professor
iao@pkuph.edu.cn88326666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026