NCT07285902Active, not recruitingPhase 3
A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 572 (actual)
- First submitted
- 3 Dec 2025
- Start date
- Dec 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07285902
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 572
- From Dec 2025 to the primary completion date, Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or known history of acute or chronic pancreatitis, pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatment-inducing gallbladder disease
- Previous or known history or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2).
- Severe infection, severe trauma, or large and medium-sized surgery within 1 month prior to screening
- History of severe cardiovascular and cerebrovascular diseases within the previous 6 months
- Use of medications or treatments that may result in significant weight gain or loss within the previous 3 months
- Received, or planned to undergo bariatric surgery or endoscopic and/or medical device-based bariatric therapy during the study, etc
- Those who have a known or suspected allergy to the same or related products of the investigational drug and their excipients
- Previous discontinuation of this class for safety/tolerability reasons
- Participation in a clinical trial of any drug or medical device within 3 months prior to screening
- Those who have donated or lost ≥ 400 mL of blood within the previous 3 months, or have received blood transfusions
- Surgery is planned for the duration of the trial
Other illness
- Presence or history of endocrine disorders that may significantly affect body weight
- History of diabetes mellitus
- Those who have had any previous disease or history that affects gastric emptying, or who have undergone gastrointestinal surgery
- Malignancy of any organ system within 5 years
- Presence or suspicion of depression, bipolar disorder, suicidal tendencies, People with schizophrenia or other more serious mental illness
- Known or suspected history of alcohol and/or drug abuse or drug abuse
- Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease
- Presence of autoimmune disease with planned use of systemic glucocorticoids or immunosuppressive therapy during the study
- Subjects who are mentally incapacitated or have language impairment who are unable to fully understand or participate in the trial process
- Investigators and relevant staff of the research center or other persons directly involved in the implementation of the program, and their immediate family members; Employees of Hengrui Company; In the judgment of the investigator, there is any condition that affects the safety of the subject or any other interference with the evaluation of the test results
Lab values
- Presence of any hematologic disorder that may interfere with HbA1c detection
Other
- Those with abnormal relevant examinations at screening;
- ECG results are abnormal and may affect the safety of the subject
- Poor blood pressure control
- The PHQ-9 score ≥ 15 points
Who the study is looking for
- With my consent and has signed the informed consent form, I am willing and able to follow the requirements of the trial protocol to complete this study;
- Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;
- obesity
- Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.
- Male and female subjects of childbearing potential (including partners) who have no fertility plan and agree to take highly effective contraceptive measures within 2 months after signing the informed consent form to the last dose, and female or male subjects of childbearing potential have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test within 3 days prior to randomization and are not lactating.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chiness PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.