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NCT06250946CompletedPhase 2

Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects

Source: ClinicalTrials.gov · Last updated 13 Apr 2025

Brief summary (registry, in English)

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
235 (actual)
First submitted
1 Feb 2024
Start date
23 Feb 2024
Primary completion date
22 Jan 2025
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Diseases
Obesity
NCT number
NCT06250946

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 235
  • From 23 Feb 2024 to the primary completion date, 22 Jan 2025
  • 1 site 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

  • Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
  • History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
  • Use of any medication or treatment that may have caused significant weight change within 2 months;
  • history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
  • Surgery is planned during the trial;

Other illness

  • Uncontrollable hypertension;
  • History of diabetes;
  • Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
  • Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
  • History of bariatric surgery;

Other

  • PHQ-9 score ≥15;
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
  • Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Who the study is looking for

  • Male or female subjects, 18-65 years of age at the time of signing informed consent;
  • At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
  • Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
  • Able and willing to provide a written informed consent

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.