A Phase 1 interventional study of HRS-1597 and Placebo in Obese and Metabolic Disorders, sponsored by Shandong Suncadia Medicine Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 78 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; 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).
Exclusion Criteria:
-
General Conditions:
Positive test results for surface antigen (HBsAg), antibody (HCV Ab), syphilis antibody, or (HIV) antibody.
History of Any of the Following Diseases or Conditions:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-1597 or placebo
Drug: HRS-1597 · Drug: Placebo
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-1597 or placebo
Drug: HRS-1597 · Drug: Placebo
Specified dose on specified days
Specified dose on specified days
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Time frame: 10 days (SAD), 41 days (MAD)
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shandong Suncadia Medicine Co., Ltd. →