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Recruiting

NCT Number: NCT06893016

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Body mass index ≥ 28 kg/m2 or ≥24kg/m² to <28 kg/m2 with at least 1 of the following weight-related comorbidities: a) Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol/L, fasting low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, fasting high-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L, or the need for at least one lipid-lowering treatment to maintain normal lipid levels; c) Obstructive sleep apnea syndrome; d) Fatty liver; e) Cardiovascular disease; e) Polycystic ovary syndrome.
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion criteria

  • Obesity known to be caused by monogenic mutations, other diseases, or medications.
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  • A history of moderate to severe depression at any time in the past or a score of ≥15 on the PHQ-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders.
  • A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.
  • Plans to quit smoking during the study period
  • Allergic constitution (allergic to multiple medications or foods), or those known to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.

Treatment and study plan

RAY1225

Drug

RAY1225 will be administered SC

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 52

    Time frame: Baseline and Week 52

  2. Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52

    Time frame: Baseline and Week 52

Secondary outcomes

  1. Change From Baseline in Waist Circumference at Week 52

    Time frame: Baseline and Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Ji, Doctor

CONTACT

[email protected]

86-10-8831-6815

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants Who Have Obesity or Are Overweight

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Jul 17, 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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