Comparing first- and second-generation HRS9531 tablets in people with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study compares the relative bioavailability, safety, and tolerability of first- versus second-generation HRS9531 tablet formulations in adult men with overweight or obesity. The protocol includes single-dose escalation of the second-generation formulation to characterize its pharmacokinetics and monitor adverse events. Participants will undergo screening, dosing, blood sampling for PK measures, and safety assessments including vital signs, labs, and ECGs. The trial is sponsored by Fujian Shengdi Pharmaceutical and conducted at The Second Affiliated Hospital of Anhui Medical University in Hefei, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Jingjing Wang
• Email: jingjing.wang@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.