ObesityPhase 3NCT06893016
Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight
A Phase 3 study testing RAY1225 in people with Obesity, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 640 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 15 Sep 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Plans to quit smoking during the study period
- 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 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
Beijing
Ji, Doctor, 86-10-8831-6815, pkuphiao@163.com
About this study
Official title: 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
The primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.
- 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
RAY1225 will be administered SC
PlaceboDrug
Placebo will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| RAY1225 High Dose | Experimental | Participants will receive RAY1225 high dose subcutaneously (SC) for 52 weeks. Receives: Drug: RAY1225 |
| RAY1225 Medium Dose | Experimental | Participants will receive RAY1225 Medium dose subcutaneously (SC) for 52 weeks. Receives: Drug: RAY1225 |
| RAY1225 Low Dose | Experimental | Participants will receive RAY1225 low dose subcutaneously (SC) for 52 weeks. Receives: Drug: RAY1225 |
| Placebo | Placebo comparator | Participants will receive placebo SC for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 52
Measured: Baseline and Week 52
Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52
Measured: Baseline and Week 52
Secondary outcomes (1)
Change From Baseline in Waist Circumference at Week 52
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Jun 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Sep 2026 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 640 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
- NCT06893016
- Sponsor's protocol ID
- RAY1225-24-07
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 17 Jul 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06893016
- Acronym / sponsor ID
- RAY1225-24-07
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 25 Mar 2025 (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 primary objective of this study is to demonstrate that RAY1225 is superior to placebo for percent change in body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RAY1225 High Dose | Experimental | Drug: RAY1225Participants will receive RAY1225 high dose subcutaneously (SC) for 52 weeks. |
| RAY1225 Medium Dose | Experimental | Drug: RAY1225Participants will receive RAY1225 Medium dose subcutaneously (SC) for 52 weeks. |
| RAY1225 Low Dose | Experimental | Drug: RAY1225Participants will receive RAY1225 low dose subcutaneously (SC) for 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC for 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Plans to quit smoking during the study period
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 |
|---|---|---|
| RAY1225RAY1225 will be administered SC | Drug | RAY1225 High Dose, RAY1225 Low Dose, RAY1225 Medium Dose |
| PlaceboPlacebo will be administered SC. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52
Time frame: Baseline and Week 52
1 secondary outcome
Change From Baseline in Waist Circumference at Week 52
Time frame: Baseline and Week 52
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 17 Jul 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 3 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 3 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 17 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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, Doctor (86-10-8831-6815, pkuphiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight at Week 52 (time frame: Baseline and Week 52). The study lists 2 primary outcomes in all. 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 17 Jul 2025.