ObesityPhase 1NCT07362030
Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin
A Phase 1 study testing RAY1225, atorvastatin calcium tablet and Metformin Tablets in people with Obesity, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
The drug-drug interaction study had been designed to investigate the effect of RAY1225 on the pharmacokinetics of digoxin, Rosuvastatin and Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- RAY1225, atorvastatin calcium tablet and Metformin Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2025to 30 Mar 2026
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥20 to ≤35 kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.
Who cannot join
- Participants with a history of hypersensitivity to study drug or any component of study medication;
- Participants had taken prescription, over-the-counter, herbal, or vitamin products within 4 weeks prior to screening；
- Smoking more than 5 cigarettes per day within 12 weeks prior to screening，or who cannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 12 weeks prior to randomization;
- Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
- Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History of dysphagia or any gastrointestinal disorder that affect absorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-Label, Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin in Healthy Participants
The drug-drug interaction study had been designed to investigate the effect of RAY1225 on the pharmacokinetics of digoxin, Rosuvastatin and
- Conditions
- Obesity
- Being tested
- RAY1225, atorvastatin calcium tablet, Metformin Tablets, Warfarin Sodium Tablets, Digoxin Tablets
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1225Drug
subcutaneous injection
atorvastatin calcium tabletDrug
Oral
Metformin TabletsDrug
Oral
Warfarin Sodium TabletsDrug
Oral
Digoxin TabletsDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Period 1: All participants took one tablet of atorvastatin calcium (20mg) and one tablet of metformin hydrochloride (500mg) in the morning of Day 1, after fasting. On the morning of Day 8, they took two tablets of warfarin sodium (5mg) and one tablet of digoxin (0.25mg) in the same fasting condition.
Period 2: All participants were injected with RAY1225 once every two weeks (a total of 7 times, with each dose ranging from 1mg to 3mg to 6mg to 6mg to 6mg to 6mg to 6mg). On D86 (24±1 hours after the 6th administration of RAY1225), they took 1 tablet of atorvastatin calcium (20mg) and 1 tablet of metformin hydrochloride (500mg) orally in an empty stomach condition with approximately 240ml of warm water. On D100 (24±1 hours after the 7th administration of RAY1225), they took 2 tablets of warfarin sodium (5mg) and 1 tablet of digoxin (0.25mg) orally in an empty stomach condition with approximately 240ml of warm water in the morning. Receives: Drug: RAY1225; Drug: atorvastatin calcium tablet; Drug: Metformin Tablets; Drug: Warfarin Sodium Tablets; Drug: Digoxin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic - Cmax
Maximum observed plasma concentration
Measured: Day 1~Day 5 and Day 86~Day 107
Pharmacokinetic -Area under the curve（AUC）
Area under the curve
Measured: Day 1~Day 5 and Day 86~Day 107
Secondary outcomes (1)
Number of participants with adverse events
The safety and tolerability of RAY1225 alone and in combination with IWarfarin, atorvastatin, metformin and digoxin will be examined.
Measured: DAY 1~Day 107
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start14 Apr 2025
- Primary completion27 Dec 2025
- Study completion30 Mar 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07362030
- Sponsor's protocol ID
- RAY1225-24-11
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 23 Jan 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-Label, Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin in Healthy Participants
- ClinicalTrials.gov ID
- NCT07362030
- Acronym / sponsor ID
- RAY1225-24-11
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 23 Jan 2026 (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 drug-drug interaction study had been designed to investigate the effect of RAY1225 on the pharmacokinetics of digoxin, Rosuvastatin and
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: RAY1225, Drug: atorvastatin calcium tablet, Drug: Metformin Tablets, Drug: Warfarin Sodium Tablets, Drug: Digoxin TabletsPeriod 1: All participants took one tablet of atorvastatin calcium (20mg) and one tablet of metformin hydrochloride (500mg) in the morning of Day 1, after fasting. On the morning of Day 8, they took two tablets of warfarin sodium (5mg) and one tablet of digoxin (0.25mg) in the same fasting condition. Period 2: All participants were injected with RAY1225 once every two weeks (a total of 7 times, with each dose ranging from 1mg to 3mg to 6mg to 6mg to 6mg to 6mg to 6mg). On D86 (24±1 hours after the 6th administration of RAY1225), they took 1 tablet of atorvastatin calcium (20mg) and 1 tablet of metformin hydrochloride (500mg) orally in an empty stomach condition with approximately 240ml of warm water. On D100 (24±1 hours after the 7th administration of RAY1225), they took 2 tablets of warfarin sodium (5mg) and 1 tablet of digoxin (0.25mg) orally in an empty stomach condition with approximately 240ml of warm water in the morning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥20 to ≤35 kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.
Key exclusion criteria (8 listed)
- Participants with a history of hypersensitivity to study drug or any component of study medication;
- Participants had taken prescription, over-the-counter, herbal, or vitamin products within 4 weeks prior to screening；
- Smoking more than 5 cigarettes per day within 12 weeks prior to screening，or who cannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 12 weeks prior to randomization;
- Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
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 |
|---|---|---|
| RAY1225subcutaneous injection | Drug | Experimental 1 |
| atorvastatin calcium tabletOral | Drug | Experimental 1 |
| Metformin TabletsOral | Drug | Experimental 1 |
| Warfarin Sodium TabletsOral | Drug | Experimental 1 |
| Digoxin TabletsOral | Drug | Experimental 1 |
Primary outcome
Pharmacokinetic - Cmax
Time frame: Day 1~Day 5 and Day 86~Day 107
Maximum observed plasma concentration
Pharmacokinetic -Area under the curve（AUC）
Time frame: Day 1~Day 5 and Day 86~Day 107
Area under the curve
1 secondary outcome
Number of participants with adverse events
Time frame: DAY 1~Day 107
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 23 Jan 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 1 study testing RAY1225, atorvastatin calcium tablet and Metformin Tablets 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 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 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?
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?
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?
Pharmacokinetic - Cmax (time frame: Day 1~Day 5 and Day 86~Day 107). 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 23 Jan 2026.