ObesePhase 1NCT05835752
The Safety, Tolerability and Pharmacokinetic Study of RAY1225
A Phase 1 study testing RAY1225 in people with Obese and Healthy, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of RAY1225 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- 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
- 68 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2023to 23 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI<28 kg/m2（Part A\&B only);BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- BMI≥28 kg/m2（Part C only）.BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
Who cannot join
- Participants with clinically significant disorders (including but not limited to, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immune, neurological, psychiatric, cutaneous, hematological disorders, retinopathy, and neoplasms etc. )within 24 weeks prior to randomization.
- Participants who are not suitable for subcutaneous injections (trauma, surgery, allergies or skin lesions, etc.).
- Known history of definite mental illness, such as depression, suicidal ideation, schizophrenia, bipolar disorder.
- 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.
- Participants who experienced a grade 3 hypoglycemic event within the 12 months prior to randomization, or experienced a hypoglycemic event (venous or terminal blood glucose <3 mmol/L ) ≥3 times or with hypoglycemia-related symptoms within 3 months prior to randomization.
- Participants with clinically significant abnormalities on ECG, or QTcF >450ms, or with a family history of long QT syndrome or a family history of Brugada syndrome.
Show all 11Show fewer
- Participants who planning to use glucagon-like peptide-1 (GLP-1) receptor agonists and GLP1-related drugs or other enteroglucagon peptides(including but not limited to: exenatide, liraglutide, lisnatide, benalutide, dulaglutide, lorcetide, semaglutide, tirzepatide), during the 12 weeks prior to randomization or during the trial.
- Participants who undergone major surgery, donated blood/bleeding profusely (> 400 mL) 12 weeks prior to randomization, donated blood/bleeding profusely (>200 mL) 4 weeks prior to randomization,or have a serious infection.
- The average daily smoking are more than 5 cigarettes within 12 weeks prior to screening or unwilling to quit smoking during the study period.
- Participants who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.
- Known presence of a single genetic mutation, other diseases or medications causing obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, growth hormone deficiency, acromegaly, pseudohypoparathyroidism, hypogonadism, or weight gain caused by increased non-fat content (e.g., edema)[Part C only]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RAY1225
This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of RAY1225
- Being tested
- RAY1225, Placebo
- Keywords
- obesity, GLP-1, GIP
- 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
Administered SC
RAY1225Drug
Administered SC
PlaceboDrug
Administered SC
RAY1225Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| RAY1225(Part A) | Experimental | Escalating doses of RAY1225 administered subcutaneously (SC) once in healthy participants. Receives: Drug: RAY1225 |
| Placebo (Part A) | Experimental | Placebo administered SC once in healthy participants. Receives: Drug: Placebo |
| RAY1225 (Part B) | Experimental | Escalating doses RAY1225 administered SC once weekly for four weeks in healthy participants. Receives: Drug: RAY1225 |
| Placebo (Part B) | Experimental | Placebo administered SC once weekly for four weeks in healthy participants. Receives: Drug: Placebo |
| RAY1225(Part C) | Experimental | Three dose levels of RAY1225 administered SC once weekly for four weeks in participants with Obese. Receives: Drug: RAY1225 |
| Placebo (Part C) | Experimental | Placebo administered SC once weekly for four weeks in participants with Obese. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Measured: Baseline through Day 29 (Part A)
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Measured: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
Secondary outcomes (4)
To determine the single oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)
Measured: Baseline through Day 29 (Part A)
To determine the multiple oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)
Measured: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
To determine the Pharmacodynamics of RAY1225(Change in Body Weight）
Measured: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
To determine the Pharmacodynamics of RAY1225（Change in Waist circumference）
Measured: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start18 May 2023
- Primary completion1 Mar 2024
- Study completion23 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
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
- NCT05835752
- Sponsor's protocol ID
- RAY1225-22-01
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RAY1225
- ClinicalTrials.gov ID
- NCT05835752
- Acronym / sponsor ID
- RAY1225-22-01
- Keywords
- obesity, GLP-1, GIP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 23 Mar 2024 (actual)
- First posted
- 28 Apr 2023 (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.
This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of RAY1225
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RAY1225(Part A) | Experimental | Drug: RAY1225Escalating doses of RAY1225 administered subcutaneously (SC) once in healthy participants. |
| Placebo (Part A) | Experimental | Drug: PlaceboPlacebo administered SC once in healthy participants. |
| RAY1225 (Part B) | Experimental | Drug: RAY1225Escalating doses RAY1225 administered SC once weekly for four weeks in healthy participants. |
| Placebo (Part B) | Experimental | Drug: PlaceboPlacebo administered SC once weekly for four weeks in healthy participants. |
| RAY1225(Part C) | Experimental | Drug: RAY1225Three dose levels of RAY1225 administered SC once weekly for four weeks in participants with Obese. |
| Placebo (Part C) | Experimental | Drug: PlaceboPlacebo administered SC once weekly for four weeks in participants with Obese. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI<28 kg/m2（Part A\&B only);BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- BMI≥28 kg/m2（Part C only）.BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
Key exclusion criteria (11 listed)
- Participants with clinically significant disorders (including but not limited to, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immune, neurological, psychiatric, cutaneous, hematological disorders, retinopathy, and neoplasms etc. )within 24 weeks prior to randomization.
- Participants who are not suitable for subcutaneous injections (trauma, surgery, allergies or skin lesions, etc.).
- Known history of definite mental illness, such as depression, suicidal ideation, schizophrenia, bipolar disorder.
- 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.
- Participants who experienced a grade 3 hypoglycemic event within the 12 months prior to randomization, or experienced a hypoglycemic event (venous or terminal blood glucose <3 mmol/L ) ≥3 times or with hypoglycemia-related symptoms within 3 months prior to randomization.
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(Part A) |
| PlaceboAdministered SC | Drug | Placebo (Part A) |
| RAY1225Administered SC | Drug | RAY1225 (Part B) |
| PlaceboAdministered SC | Drug | Placebo (Part B) |
| RAY1225Administered SC | Drug | RAY1225(Part C) |
| PlaceboAdministered SC | Drug | Placebo (Part C) |
Primary outcome
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
Time frame: Baseline through Day 29 (Part A)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
Time frame: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
4 secondary outcomes
To determine the single oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)
Time frame: Baseline through Day 29 (Part A)
To determine the multiple oral dose pharmacokinetic profiles of RAY1225(AUC0-∞)
Time frame: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
To determine the Pharmacodynamics of RAY1225(Change in Body Weight）
Time frame: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
To determine the Pharmacodynamics of RAY1225（Change in Waist circumference）
Time frame: Baseline through Day 64 (QW,Part B&C);baseline through Day 71 (Q2W,Part B&C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAY1225 in people with Obese and Healthy, 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 5 Mar 2026. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) (time frame: Baseline through Day 29 (Part A)). 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 5 Mar 2026.