T2DMPhase 3NCT07139548
A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes
A Phase 3 study testing RAY1225 and Semaglutide in people with T2DM, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM
- What is being tested?
- RAY1225 and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 31 Dec 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
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between ≥7.0% and ≤11.5%
- Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
- Be of stable weight (±5%) for at least 12 weeks before screening
Who cannot join
- Have type 1 diabetes mellitus
- Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
- Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose <3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
- History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
- Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);
- Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes
The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.
- Conditions
- T2DM
- Being tested
- RAY1225, Semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1225Drug
Administered SC
SemaglutideDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 6mg RAY1225 | Experimental | 6 milligrams (mg) RAY1225 administered subcutaneously (SC) once every two week. Receives: Drug: RAY1225 |
| 9mg RAY1225 | Experimental | 9 mg RAY1225 administered subcutaneously (SC) once every two week. Receives: Drug: RAY1225 |
| 1 mg Semaglutide | Active comparator | 1 mg semaglutide administered SC once a week. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg)
HbA1c is the glycosylated fraction of hemoglobin A.
Measured: Baseline,36 Week
Secondary outcomes (5)
Percentage of Participants Achieving an HbA1c Target Value of <7%
Measured: Baseline,36 Week
Percentage of Participants With HbA1c Target Value of <6.5%
Measured: Baseline,36 Week
Percentage of Participants With HbA1c Target Value of <5.7%
Measured: Baseline,36 Week
Mean change in fasting serum glucose
Measured: Baseline,36 Week
Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline
Measured: Baseline,36 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies 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
- 600 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
- NCT07139548
- Sponsor's protocol ID
- RAY1225-24-13
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 24 Aug 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07139548
- Acronym / sponsor ID
- RAY1225-24-13
- Conditions
- T2DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Aug 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 reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6mg RAY1225 | Experimental | Drug: RAY12256 milligrams (mg) RAY1225 administered subcutaneously (SC) once every two week. |
| 9mg RAY1225 | Experimental | Drug: RAY12259 mg RAY1225 administered subcutaneously (SC) once every two week. |
| 1 mg Semaglutide | Active comparator | Drug: Semaglutide1 mg semaglutide administered SC once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between ≥7.0% and ≤11.5%
- Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
- Be of stable weight (±5%) for at least 12 weeks before screening
Key exclusion criteria (7 listed)
- Have type 1 diabetes mellitus
- Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
- Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose <3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
- History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
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 | 6mg RAY1225, 9mg RAY1225 |
| SemaglutideAdministered SC | Drug | 1 mg Semaglutide |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg)
Time frame: Baseline,36 Week
HbA1c is the glycosylated fraction of hemoglobin A.
5 secondary outcomes
Percentage of Participants Achieving an HbA1c Target Value of <7%
Time frame: Baseline,36 Week
Percentage of Participants With HbA1c Target Value of <6.5%
Time frame: Baseline,36 Week
Percentage of Participants With HbA1c Target Value of <5.7%
Time frame: Baseline,36 Week
Mean change in fasting serum glucose
Time frame: Baseline,36 Week
Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline
Time frame: Baseline,36 Week
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 24 Aug 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 and Semaglutide in people with T2DM, 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Aug 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. 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 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 Hemoglobin A1c (HbA1c) (6 mg and 9 mg) (time frame: Baseline,36 Week). 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 24 Aug 2025.