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NCT Number: NCT06254261

A Study of RAY1225 in Participants With Obesity

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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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijingcun, Hebei, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

RAY1225

Drug

Administered SC

Placebo

Drug

Placebo

Primary outcomes

  1. Change From Baseline in Body Weight

    Time frame: Baseline,Week26

    Percent Change from Baseline in Body Weight

Secondary outcomes

  1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Time frame: Baseline,Week26

  2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame: Baseline,Week26

  3. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame: Baseline,Week26

  4. Change from Baseline in Waist Circumference in Centimeter

    Time frame: Baseline,Week26

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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