NCT07150962 Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects
| NCT ID | NCT07150962 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Overweight or Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 168 participants in total. It began in 2025-10-15 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07150962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Overweight or Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07150962 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07150962 currently recruiting?
Yes, NCT07150962 is actively recruiting participants. Contact the research team at jingjing.wang@hengrui.com for enrollment information.
Where is the NCT07150962 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07150962 clinical trial?
NCT07150962 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 168 participants.
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