ObesityPhase 2NCT06254261
A Study of RAY1225 in Participants With Obesity
A Phase 2 study testing RAY1225 in people with Obesity, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- RAY1225
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2024to 20 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
- allergic constitution;
- not suitable for subcutaneous injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijingcun, Hebei
JI, professor, 88326666, iao@pkuph.edu.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
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.
- Conditions
- Obesity
- Being tested
- RAY1225, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1225Drug
Administered SC
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RAY1225 (cohort 1) | Experimental | Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks. Receives: Drug: RAY1225 |
| Placebo (cohort 1) | Placebo comparator | Participants received Placebo administered SC once two weeks for 24 weeks. Receives: Drug: Placebo |
| RAY1225 (cohort 2) | Experimental | Escalating doses of RAY1225 administered subcutaneously (SC) once two week Receives: Drug: RAY1225 |
| Placebo (cohort 2) | Placebo comparator | Participants received Placebo administered SC once two week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight
Percent Change from Baseline in Body Weight
Measured: Baseline,Week26
Secondary outcomes (4)
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Measured: Baseline,Week26
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Measured: Baseline,Week26
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Measured: Baseline,Week26
Change from Baseline in Waist Circumference in Centimeter
Measured: Baseline,Week26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start21 Feb 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254261
- Sponsor's protocol ID
- RAY1225-23-02
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06254261
- Acronym / sponsor ID
- RAY1225-23-02
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RAY1225 (cohort 1) | Experimental | Drug: RAY1225Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks. |
| Placebo (cohort 1) | Placebo comparator | Drug: PlaceboParticipants received Placebo administered SC once two weeks for 24 weeks. |
| RAY1225 (cohort 2) | Experimental | Drug: RAY1225Escalating doses of RAY1225 administered subcutaneously (SC) once two week |
| Placebo (cohort 2) | Placebo comparator | Drug: PlaceboParticipants received Placebo administered SC once two week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
- allergic constitution;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAY1225Administered SC | Drug | RAY1225 (cohort 1), RAY1225 (cohort 2) |
| PlaceboPlacebo | Drug | Placebo (cohort 1), Placebo (cohort 2) |
Primary outcome
Change From Baseline in Body Weight
Time frame: Baseline,Week26
Percent Change from Baseline in Body Weight
4 secondary outcomes
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame: Baseline,Week26
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame: Baseline,Week26
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame: Baseline,Week26
Change from Baseline in Waist Circumference in Centimeter
Time frame: Baseline,Week26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAY1225 in people with Obesity, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JI, professor (88326666, iao@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Body Weight (time frame: Baseline,Week26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.