Once-weekly tirzepatide injections for adults with obesity or overweight and weight-related conditions

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

Adults aged 18 or older without type 2 diabetes who have a BMI ≥30 kg/m² or BMI ≥27 kg/m² with at least one weight-related comorbidity are randomized 1:1:1:1 to receive once-weekly subcutaneous tirzepatide (5, 10, or 15 mg) or placebo using an autoinjector, with all participants receiving counseling on a reduced-calorie diet and increased physical activity. The main treatment period is 72 weeks and the primary efficacy assessment occurs at Week 72. Participants with prediabetes at randomization may continue treatment for up to 176 weeks to evaluate longer-term weight outcomes and time to onset or progression to type 2 diabetes. Safety is monitored throughout the trial with regular adverse event reporting and laboratory tests.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* BMI ≥30 kg/m², OR BMI ≥27 kg/m² with ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)
* History of at least one unsuccessful dietary effort to lose weight (self-reported)
* Investigator judges participant capable and willing to self-inject (or have assistance), follow lifestyle advice, maintain a diary, and complete questionnaires
* Age ≥18 years
* Meets protocol contraception/pregnancy criteria (as applicable) and provides written informed consent

Exclusion Criteria:

* Type 1 or type 2 diabetes, history of ketoacidosis/hyperosmolar state, or screening labs diagnostic of diabetes
* Recent significant weight change (\>5 kg within 3 months prior to screening)
* Prior/planned bariatric surgery; recent/ongoing endoscopic or device-based obesity therapies
* Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
* Clinically significant gastric emptying abnormality or chronic use of drugs that directly affect GI motility
* History of chronic or acute pancreatitis
* Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study
* Obesity due to other endocrinologic disorders (e.g., Cushing syndrome) or monogenic/syndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome)
* Significant unstable major depressive disorder/severe psychiatric disorder, lifetime suicide attempt, or concerning suicidality screening (PHQ-9/C-SSRS criteria)
* Uncontrolled hypertension; recent major cardiovascular events; NYHA class IV heart failure
* Active or significant liver disease or certain elevated liver tests at screening (per protocol thresholds)
* Elevated calcitonin above protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2
* Active/untreated malignancy or remission \<5 years (with specified exceptions)
* Any other condition contraindicating GLP-1 receptor agonist therapy

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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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.