Health TrialsbyHealthPanel

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

ConditionObesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Raynovent Biotech Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAY1225

    Drug

    RAY1225 will be administered SC

  • Placebo

    Drug

    Placebo will be administered SC.

Treatment groups

640 Participants
are divided into 4 treatment groups
Group A: RAY1225 High DoseExperimental treatment 1 intervention
Group B: RAY1225 Medium DoseExperimental treatment 1 intervention
Group C: RAY1225 Low DoseExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Raynovent Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now