Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight

Last updated: July 15, 2025
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

RAY1225

Placebo

Clinical Study ID

NCT06893016
RAY1225-24-07
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years.

  2. Body mass index ≥ 28 kg/m2 or ≥24kg/m² to <28 kg/m2 with at least 1 of the followingweight-related comorbidities: a) Systolic blood pressure ≥130 mmHg or diastolicblood pressure ≥85 mmHg, or the use of at least one antihypertensive medication tomaintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol/L, fastinglow-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, fasting high-densitylipoprotein cholesterol (HDL-C) <1.04 mmol/L, or the need for at least onelipid-lowering treatment to maintain normal lipid levels; c) Obstructive sleep apneasyndrome; d) Fatty liver; e) Cardiovascular disease; e) Polycystic ovary syndrome.

  3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet andexercise.

Exclusion

Exclusion Criteria:

  1. Obesity known to be caused by monogenic mutations, other diseases, or medications.

  2. Family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2.

  3. A history of moderate to severe depression at any time in the past or a score of ≥15on the PHQ-9 questionnaire at screening; a history of bipolar disorder,schizophrenia, or other severe psychiatric disorders.

  4. A history of organ transplantation (excluding corneal transplant), or beingcurrently prepared to undergo organ transplantation.

  5. Plans to quit smoking during the study period

  6. Allergic constitution (allergic to multiple medications or foods), or those known tobe allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.

Study Design

Total Participants: 640
Treatment Group(s): 2
Primary Treatment: RAY1225
Phase: 3
Study Start date:
June 15, 2025
Estimated Completion Date:
September 15, 2026

Connect with a study center

  • Peking University People's Hospital

    Beijing,
    China

    Active - Recruiting

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