See if IBI362 lowers blood pressure in adults who are overweight or obese

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 is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of IBI362 in adults with mild to moderate hypertension and overweight/obesity who have not previously taken antihypertensive medications or have only briefly tried one type. Participants will receive injections of IBI362 or placebo over a defined period while maintaining stable diet and exercise patterns. Blood pressure outcomes and safety data will be collected to determine if IBI362 provides additional blood pressure reductions with an acceptable safety profile. The study is conducted at Ruijin Hospital, Shanghai, under Innovent Biologics as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years old at the time of signing the informed consent form.
2. Confirmed diagnosis of hypertension.
3. No prior history of antihypertensive medication treatment at screening; or previously received only one type of antihypertensive medication during the same period and has discontinued all antihypertensive medications for at least 2 weeks prior to screening.
4. Voluntarily sign the informed consent form and be willing to strictly comply with the requirements and restrictions stated in the informed consent form and the protocol throughout the study, including but not limited to: maintaining a stable diet and exercise routine, receiving the study drug injections as scheduled, and keeping a study diary.

Exclusion Criteria:

1. The investigator suspects that the participant may be allergic to the components of the study drug or drugs of the same class.
2. History of orthostatic hypotension, or blood pressure measured at screening meeting the criteria for orthostatic hypotension.
3. History or diagnostic evidence of secondary hypertension other than obstructive sleep apnea, including but not limited to: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
4. Concurrent use of beta-blockers within 1 month prior to screening.
5. Self-reported body weight change \> 5 kg within 3 months.
6. History of acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), large artery aneurysm or dissecting aneurysm, transient ischemic attack (TIA), cerebrovascular accident, severe arrhythmia (e.g., ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, second-degree or higher atrioventricular block, sick sinus syndrome, etc.) within 6 months; or history of decompensated heart failure or heart failure of New York Heart Association (NYHA) Class III or IV; or history of severe diseases such as epilepsy or syncope, which the investigator deems unsuitable for trial participation.
7. Confirmed diagnosis of diabetes mellitus, or laboratory tests showing glycated hemoglobin (HbA1c) ≥ 6.5%, fasting blood glucose ≥ 7 mmol/L and/or random blood glucose ≥ 11.1 mmol/L.
8. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, acute cholangitis, or symptomatic/treated gallbladder disease (except for participants who have undergone cholecystectomy and are judged eligible by the investigator); or serum amylase or lipase \> 2.0 × Upper Limit of Normal (ULN); or fasting serum triglycerides ≥ 5.64 mmol/L (500 mg/dl).
9. Chronic gastrointestinal diseases or systemic diseases that may affect gastrointestinal motility at screening, or use of drugs that may alter gastrointestinal motility, appetite or absorption within 3 months prior to screening.
10. History or relevant family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.

Where it's running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jie Wei
• Email: jie.wei@innoventbio.com
• Phone: 0512-69566088

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Monthly dose of PF-08653944 vs placebo in Chinese adults who are overweight or obese

  This study tests whether berobenatide (PF-08653944) given once a month helps adults in China lose weight compared with a placebo.

  Recruiting Phase 3 Pfizer · Hefei, Anhui and 5 other locations · NCT07874633

• FutureShape Family: a family-based weight-management program with semaglutide for children and parents

  This trial tests whether a family-centered program that combines a prescription medication (semaglutide) with lifestyle support and app-based coaching can help adults with obesity and their children who are overweight/obese.

  Recruiting Phase 4 University of Copenhagen · Copenhagen · NCT07872904

• Home self-administration of a weight-management medicine with an autoinjector in adults who are overweight or obese

  This study tests whether adults who are overweight or have obesity can successfully self-administer maridebart cafraglutide at home using an autoinjector.

  Recruiting at 25 sites Phase 3 Amgen · San Diego, California and 24 other locations · NCT07871409

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.