RAY1225 for adults with overweight or obesity.

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

This treatment tests whether RAY1225 helps adults with overweight or obesity lose a greater percentage of body weight than a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Raynovent Biotech Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06893016 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional trial compares RAY1225 with a placebo in adult participants who are overweight or have obesity. Eligible participants must be at least 18 years old with a BMI ≥28 kg/m2 or a BMI of 24–<28 kg/m2 plus at least one weight-related comorbidity, and must report at least one prior unsuccessful attempt at weight loss by diet and exercise. Participants are assigned to receive either RAY1225 or placebo and the primary endpoint is percent change in body weight from baseline. The trial is sponsored by Guangdong Raynovent Biotech and conducted at Peking University People's Hospital in Beijing.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI ≥28 kg/m2, or BMI 24–<28 kg/m2 plus at least one weight-related comorbidity and a history of at least one unsuccessful diet-and-exercise weight-loss attempt are the intended participants.

Not a fit: Patients whose obesity is caused by monogenic mutations, other diseases, or medications, or those with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, RAY1225 could provide a new medication option that produces greater percentage weight loss for adults with overweight or obesity.

How similar studies have performed: Other phase 3 programs of modern weight-loss medications (for example, GLP-1 receptor agonists) have shown substantial weight reduction, but RAY1225 is a newer compound now being tested in a pivotal phase 3 setting.

Eligibility criteria

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

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 multiple endocrine neoplasia syndrome type 2.
3. 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.
4. A history of organ transplantation (excluding corneal transplant), or being currently 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 to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Ji, Doctor

Conditions Obesity