A Study of RAY1225 in Participants With Obesity

NCT06254261 | Recruiting Phase 2

• 1 other identifier: RAY1225-23-02
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight

  Percent Change from Baseline in Body Weight

  Baseline,Week26

Secondary Outcomes (4)

• Percentage of Participants Who Achieve ≥10% Body Weight Reduction

  Baseline,Week26

• Percentage of Participants Who Achieve ≥15% Body Weight Reduction

  Baseline,Week26

• Percentage of Participants Who Achieve ≥5% Body Weight Reduction

  Baseline,Week26

• Change from Baseline in Waist Circumference in Centimeter

  Baseline,Week26

Study Arms (4)

RAY1225 (cohort 1)

EXPERIMENTAL

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

Drug: RAY1225

Placebo (cohort 1)

PLACEBO COMPARATOR

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

Drug: Placebo

RAY1225 (cohort 2)

EXPERIMENTAL

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

Drug: RAY1225

Placebo (cohort 2)

PLACEBO COMPARATOR

Participants received Placebo administered SC once two week

Drug: Placebo

Interventions

RAY1225 DRUG

Administered SC

RAY1225 (cohort 1); RAY1225 (cohort 2)

Placebo DRUG

Placebo

Placebo (cohort 1); Placebo (cohort 2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijingcun, Hebei, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

JI, professor

CONTACT

88326666; iao@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 12, 2024
• Study Start: February 21, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-02

Locations

CN (1)