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

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

This study will test whether the second-generation HRS9531 tablet is absorbed differently and is as safe and tolerable as the first-generation tablet in adults who are overweight or obese.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07150962 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are male adults aged 18–55 with BMI 24.0–35.0 kg/m2, body weight ≥65 kg, stable weight over the past 3 months, and who are medically cleared after screening.

Not a fit: Women, people outside the specified age or BMI ranges, or those with known allergy to the drug components or significant chronic medical conditions are not eligible and are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, this could identify a second-generation HRS9531 formulation with similar or improved absorption and acceptable safety, supporting further clinical development.

How similar studies have performed: Bioavailability and single-dose pharmacokinetic comparisons are standard and have informed development of other drugs, but this specific HRS9531 formulation is new and has not yet been tested in larger efficacy trials.

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.

Where this trial is running

Hefei, Anhui

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

Study contacts

• Study coordinator: Jingjing Wang

Conditions Overweight or Obesity