A Study of RAY1225 in Participants With Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2025-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RAY1225 (cohort 1)

Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.

Group Type EXPERIMENTAL

RAY1225

Intervention Type DRUG

Administered SC

Placebo (cohort 1)

Participants received Placebo administered SC once two weeks for 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

RAY1225 (cohort 2)

Escalating doses of RAY1225 administered subcutaneously (SC) once two week

Group Type EXPERIMENTAL

RAY1225

Intervention Type DRUG

Administered SC

Placebo (cohort 2)

Participants received Placebo administered SC once two week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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RAY1225

Administered SC

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No