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Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects
A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation
Lead sponsor
Asset
HRS9531
Oral · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
1
Enrollment
168
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI 24-35
Primary endpoints
•Area under the curve•Treatment-emergent AEs (any)•Serious AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
2. Male subjects aged 18-55 years on the date of signing informed consent (inclusive);
3. Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
4. The weight change within the previous 3 months should not exceed 5 kilograms.
5. Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included.
Exclusion criteria
1. Those who are known or suspected to be allergic to any component of the investigational drug or related products; or those who have a history of multiple or severe allergies to drugs or foods, or a history of severe immediate allergic reactions;
2. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
3. Having a history of hypertension or when the researchers determine during the screening that the blood pressure is abnormal and has clinical significance;
4. Those with a history of obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), conditions that affect gastric emptying (such as pyloric stenosis), or who have undergone any gastrointestinal surgery (such as weight loss surgery; except for intestinal polyp resection and appendectomy), or who had acute diarrhea within the previous 7 days; diarrhea is defined as watery stools and/or more than 3 bowel movements per day;
5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;
7. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
8. Those who have a history of drug abuse or drug use, or who have a positive result in the urine drug screening test during the screening period;
9. Heavy drinkers (average weekly alcohol consumption of ≥ 14 units in the six months prior to screening: 1 unit of beer = 285 mL, or spirits = 25 mL, or wine = 100 mL; average daily smoking ≥ 5 cigarettes); those unable to quit smoking and drinking during the trial; those with positive alcohol blood tests.
Endpoints (7)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
7 endpointsArea under the curve from Time Zero to Time of last quantifiable concentration (AUCtau)
Time frame:From Day 14 to Day 15.
AUC₀–∞
concentration, descriptive
Adverse event (AE)
Time frame:Screening period up to Day 35.
Treatment-emergent AEs (any)
event count, event
Serious adverse event (SAE)
Time frame:Screening period up to Day 35.
Serious AEs (any)
event count, event
The maximum plasma concentration (Cmax)
Time frame:On the 35th day after continuous administration.
Cmax
concentration, descriptive
Time to maximum plasma concentration (Tmax)
Time frame:On the 35th day after continuous administration.
Tmax
descriptive
Area under the concentration-time curve (AUC)
Time frame:On the 35th day after continuous administration.
AUC₀–∞
concentration, descriptive
Time to maximum plasma concentration (Tmax)
Time frame:Post-dose from Day 1 to Day 183.
Tmax
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.