Obese and Metabolic DisordersPhase 1NCT07808918
Safety and Pharmacokinetics of HRS-1597 Tablets in Healthy and Obese Participants: A Phase 1 Study
A Phase 1 study testing HRS-1597 in people with Obese and Metabolic Disorders, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese and Metabolic Disorders
- What is being tested?
- HRS-1597
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to 30 Dec 2027
- 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
- Aged 18 to 55 years (inclusive), both male and female.
- Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 19-26 kg/m² (inclusive).
- Part 2 (MAD): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 28-35 kg/m² (inclusive).
- Male and female participants of childbearing potential and their partners agree to have no plans for pregnancy or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last dose, and voluntarily agree to use highly effective contraceptive measures. Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose (baseline period), and must not be lactating.
Who cannot join
- -
- General Conditions:
- Smoking more than 5 cigarettes (or other nicotine-containing products) per day within 3 months prior to screening, or planning to use any tobacco products during the study period.
- History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture.
- Clinically significant abnormalities in physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, and coagulation function), chest imaging, abdominal ultrasound, or 12-lead electrocardiogram (ECG), as judged by the investigator.
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), syphilis antibody, or human immunodeficiency virus (HIV) antibody.
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- History of Any of the Following Diseases or Conditions:
- Suspected allergy to the investigational product or any of its components, or a history of severe allergy to any drug, food, toxin, or other exposure.
- History of liver disease.
- History of diabetes or pre-diabetes.
- Diagnosis of malignancy or history of malignant tumors.
- History of any clinically significant disease or condition that, in the investigator's opinion, may affect the study results, including but not limited to disorders of the circulatory, endocrine, neurological, digestive, urinary, hematopoietic, immune, psychiatric, or metabolic systems; or any condition that may affect the study results, drug absorption, distribution, metabolism, or excretion, or place the participant at undue risk.
- Current or Prior Use of the Following Medications:
- Use of any prescription drugs, over-the-counter drugs (including natural health products, with the exception of routine vitamins), herbal medicines, or live (attenuated) vaccines within 1 month or 5 half-lives of the drug (whichever is longer) prior to baseline.
- Refusal to abstain from any beverages or foods containing methylxanthines (e.g., coffee, tea, cola, chocolate, etc.) from 48 hours prior to baseline through the end of the study; refusal to abstain from any beverages or foods containing grapefruit from 7 days prior to baseline through the end of the study; or special dietary requirements that prevent compliance with a standardized diet.
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
The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 310000
Zhaoyi Yang
About this study
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1597 Tablets Following Single-Dose Administration in Healthy Participants and Multiple-Dose Administration in Obese Participants, and the Effect of Food on the Pharmacokinetics of HRS-1597 Tablets
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.
- Conditions
- Obese and Metabolic Disorders
- Being tested
- HRS-1597, Placebo
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1597Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-1597 or placebo Receives: Drug: HRS-1597; Drug: Placebo |
| multiple ascending dose (MAD) cohorts | Experimental | Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-1597 or placebo Receives: Drug: HRS-1597; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Measured: 10 days (SAD), 41 days (MAD)
Secondary outcomes (10)
PK parameters of HRS-1597 in plasma and urine : Cmax
Measured: Days 1-34
PK parameters of HRS-1597 in plasma and urine : Tmax
Measured: Days 1-34
PK parameters of HRS-1597 in plasma and urine : AUC
Measured: Days 1-34
PK parameters of HRS-1597 in plasma and urine : CL/F
Measured: Days 1-34
PK parameters of HRS-1597 in plasma and urine : CLR
Measured: Days 1-34
PK parameters of HRS-1597 in plasma and urine : Vz/F
Measured: Days 1-34
PD endpoint (Fasting blood glucose)of HRS-1597
Measured: Baseline-Day 34
PD endpoint (Fasting serum insulin)of HRS-1597
Measured: Baseline-Day 34
PD endpoint (Fasting C-peptide)of HRS-1597
Measured: Baseline-Day 34
PD endpoint (HOMA-IR)of HRS-1597
Measured: Baseline-Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese and Metabolic DisordersStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-center, randomized, double-blind, placebo-controlled study comprises a single-ascending dose and food-effect part in 42 healthy participants, and a multiple-ascending dose part in 36 obese participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808918
- Sponsor's protocol ID
- HRS-1597-101
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1597 Tablets Following Single-Dose Administration in Healthy Participants and Multiple-Dose Administration in Obese Participants, and the Effect of Food on the Pharmacokinetics of HRS-1597 Tablets
- ClinicalTrials.gov ID
- NCT07808918
- Acronym / sponsor ID
- HRS-1597-101
- Conditions
- Obese and Metabolic Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Sep 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.
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-center, randomized, double-blind, placebo-controlled study comprises a single-ascending dose and food-effect part in 42 healthy participants, and a multiple-ascending dose part in 36 obese participants.
| Arm | Type | Receives |
|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Drug: HRS-1597, Drug: PlaceboSubjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-1597 or placebo |
| multiple ascending dose (MAD) cohorts | Experimental | Drug: HRS-1597, Drug: PlaceboSubjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-1597 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 55 years (inclusive), both male and female.
- Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 19-26 kg/m² (inclusive).
- Part 2 (MAD): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 28-35 kg/m² (inclusive).
- Male and female participants of childbearing potential and their partners agree to have no plans for pregnancy or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last dose, and voluntarily agree to use highly effective contraceptive measures. Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose (baseline period), and must not be lactating.
Key exclusion criteria (15 listed)
- -
- Smoking more than 5 cigarettes (or other nicotine-containing products) per day within 3 months prior to screening, or planning to use any tobacco products during the study period.
- History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture.
- Clinically significant abnormalities in physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, and coagulation function), chest imaging, abdominal ultrasound, or 12-lead electrocardiogram (ECG), as judged by the investigator.
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), syphilis antibody, or human immunodeficiency virus (HIV) antibody.
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 |
|---|---|---|
| HRS-1597Specified dose on specified days | Drug | multiple ascending dose (MAD) cohorts, single ascending dose (SAD) cohorts |
| PlaceboSpecified dose on specified days | Drug | multiple ascending dose (MAD) cohorts, single ascending dose (SAD) cohorts |
Primary outcome
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Time frame: 10 days (SAD), 41 days (MAD)
10 secondary outcomes
PK parameters of HRS-1597 in plasma and urine : Cmax
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : Tmax
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : AUC
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : CL/F
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : CLR
Time frame: Days 1-34
PK parameters of HRS-1597 in plasma and urine : Vz/F
Time frame: Days 1-34
PD endpoint (Fasting blood glucose)of HRS-1597
Time frame: Baseline-Day 34
PD endpoint (Fasting serum insulin)of HRS-1597
Time frame: Baseline-Day 34
PD endpoint (Fasting C-peptide)of HRS-1597
Time frame: Baseline-Day 34
PD endpoint (HOMA-IR)of HRS-1597
Time frame: Baseline-Day 34
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 9 Sep 2026.
- 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 1 study testing HRS-1597 in people with Obese and Metabolic Disorders, run by Shandong Suncadia Medicine 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 15 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 9 Sep 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?
Contact Lei Zhang (0518-82342973, lei.zhang.lz177@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: incidence of adverse event (AE), serious adverse event (SAE) (time frame: 10 days (SAD), 41 days (MAD)). 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 9 Sep 2026.