T2DM (Type 2 Diabetes Mellitus)Phase 2NCT06254274
A Study of RAY1225 in Participants With Type 2 Diabetes
A Phase 2 study testing RAY1225 in people with T2DM (Type 2 Diabetes Mellitus), 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 type 2 diabetes mellitus. 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
- T2DM (Type 2 Diabetes Mellitus)
- 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
- 210 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2024to 8 Sep 2025
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:
- have T2DM controlled with diet and exercise alone;
- are stable in dose and type on a single or in a combination of oral antidiabetic medication, metformin, α-glucosidase inhibitors or SGLT-2 inhibitors only ,within 12 weeks before screening;
- BMI ≥ 20 kg/m²；
- Fasting blood-glucose（FPG）<15 mmol/L;
- Weight change < 5% in the 12 weeks before screening;
- 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
- have type 1 diabetes mellitus；
- Severe diabetic complications, including proliferative retinopathy or maculopathy, severe diabetic neuropathy (e.g., urinary retention, urinary incontinence, and painful peripheral neuropathy), resting tachycardia, orthostatic hypotension, intermittent claudication, or diabetic foot;
- Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;
- had grade 3 hypoglycemic events within 12 months before screening,
- Three or more grade 2 hypoglycemic events occurred within 3 months before screening;
- Have symptoms related to hypoglycemia at screening;
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- Within 6 weeks before screening, serious trauma, serious infection, or surgery that may have affected glycemic control was reported;
- 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 locations and contacts
1 site in 1 country.
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 Type 2 Diabetes
The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with type 2 diabetes mellitus. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- RAY1225, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
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
| 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 Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A.
Measured: Baseline,Week 24
Secondary outcomes (4)
Percentage of Participants With HbA1c Target Value of <6.5%
Measured: Baseline,Week24
Percentage of Participants With HbA1c Target Value of <7%
Measured: Baseline,Week24
Percentage of Participants With HbA1c Target Value of <5.7%
Measured: Baseline,Week24
Change From Baseline in Fasting Serum Glucose
Measured: Baseline,Week24
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 start26 Feb 2024
- Primary completion20 Jul 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies 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
- 210 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
- NCT06254274
- Sponsor's protocol ID
- RAY1225-23-03
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. 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 Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06254274
- Acronym / sponsor ID
- RAY1225-23-03
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- 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 type 2 diabetes mellitus. 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 (7 listed)
- Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:
- BMI ≥ 20 kg/m²；
- Fasting blood-glucose（FPG）<15 mmol/L;
- Weight change < 5% in the 12 weeks before screening;
- 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 (9 listed)
- have type 1 diabetes mellitus；
- Severe diabetic complications, including proliferative retinopathy or maculopathy, severe diabetic neuropathy (e.g., urinary retention, urinary incontinence, and painful peripheral neuropathy), resting tachycardia, orthostatic hypotension, intermittent claudication, or diabetic foot;
- Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;
- had grade 3 hypoglycemic events within 12 months before screening,
- Three or more grade 2 hypoglycemic events occurred within 3 months before screening;
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) |
| PlaceboAdministered SC | Drug | Placebo (cohort 1), Placebo (cohort 2) |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline,Week 24
HbA1c is the glycosylated fraction of hemoglobin A.
4 secondary outcomes
Percentage of Participants With HbA1c Target Value of <6.5%
Time frame: Baseline,Week24
Percentage of Participants With HbA1c Target Value of <7%
Time frame: Baseline,Week24
Percentage of Participants With HbA1c Target Value of <5.7%
Time frame: Baseline,Week24
Change From Baseline in Fasting Serum Glucose
Time frame: Baseline,Week24
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 26 Oct 2026.
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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 2 study testing RAY1225 in people with T2DM (Type 2 Diabetes Mellitus), 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 7 inclusion and 9 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 26 Oct 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. 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?
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?
Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline,Week 24). 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 26 Oct 2026.