Health TrialsbyHealthPanel

A Study of RAY1225 in Participants With Obesity

ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuangdong Raynovent Biotech Co., Ltd

About this trial

The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and < 6.5%;

Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Disqualifiers

Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity

with a history of diabetes or hypoglycemia;

Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.

Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAY1225

    Drug

    Administered SC

  • Placebo

    Drug

    Placebo

Treatment groups

270 Participants
are divided into 4 treatment groups
Group A: RAY1225 (cohort 1)Experimental treatment 1 intervention
Group B: Placebo (cohort 1)Placebo comparator 1 intervention
Group C: RAY1225 (cohort 2)Experimental treatment 1 intervention
Group D: Placebo (cohort 2)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Body Weight

Percent Change from Baseline in Body Weight

Time frame
Baseline,Week26

Secondary outcomes

1

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame
Baseline,Week26
2

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame
Baseline,Week26
3

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame
Baseline,Week26
4

Change from Baseline in Waist Circumference in Centimeter

Time frame
Baseline,Week26

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
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