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

Guangdong Raynovent Biotech

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo; Drug: RAY1225

Study type: Interventional

Funder types: Industry

Identifiers

NCT06893016

RAY1225-24-07

Details and patient eligibility

About

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

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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640 participants in 4 patient groups, including a placebo group

RAY1225 High Dose

Experimental group

Description:

Participants will receive RAY1225 high dose subcutaneously (SC) for 52 weeks.

Treatment:

Drug: RAY1225

RAY1225 Medium Dose

Experimental group

Description:

Participants will receive RAY1225 Medium dose subcutaneously (SC) for 52 weeks.

Treatment:

Drug: RAY1225

RAY1225 Low Dose

Experimental group

Description:

Participants will receive RAY1225 low dose subcutaneously (SC) for 52 weeks.

Treatment:

Drug: RAY1225

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC for 52 weeks.

Treatment:

Drug: Placebo