A Study of RAY1225 in Participants With Obesity

Guangdong Raynovent Biotech

Status and phase: Enrolling; Phase 2

Conditions: Obesity

Treatments: Drug: RAY1225; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06254261

RAY1225-23-02

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 4 patient groups, including a placebo group

RAY1225 (cohort 1)

Experimental group

Description:

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

Treatment:

Drug: RAY1225

Placebo (cohort 1)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

RAY1225 (cohort 2)

Experimental group

Description:

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

Treatment:

Drug: RAY1225

Placebo (cohort 2)

Placebo Comparator group

Description:

Participants received Placebo administered SC once two week

Treatment:

Drug: Placebo