Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity

Lab values

• 1\. History of type 1 or type 2 diabetes mellites. 2. Obesity-related:
  • A self-reported change in body weight \>5 kg (11 lbs) within 90 days before screening irrespective of medical records.
  • Treatment with any medication for the indication of obesity within the past 90 days before screening.
  • Current use, or use within 90 days before screening, of medications with the potential to increase body weight (e.g., systemic glucocorticosteroids, antipsychotics, antidepressants, and antiepileptics) or to reduce body weight (e.g., diuretics).
  • Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening; (2) lap banding, if the band has been removed \>1 year before screening; (3) intragastric balloon, if the balloon has been removed \>1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening.
  • Uncontrolled thyroid disease, defined as thyroid stimulating hormone \>6.0 mIU/L or \<0.4 mIU/L as measured by the central laboratory at screening.
  • 3\. Mental health:
  • History of major depressive disorder within 2 years before screening.
  • Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).
  • A Patient Health Questionnaire-9 score of ≥15 at screening.
  • A lifetime history of a suicidal attempt.
  • Suicidal behavior within 30 days before screening. 4. General safety:
  • Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening.
  • Presence of acute pancreatitis within the past 180 days prior to the day of screening.
  • History or presence of chronic pancreatitis.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Renal impairment measured as estimated glomerular filtration rate value of \<15 mL/min/1.73 m2 as defined by KDIGO 2012 by the central laboratory at screening.
  • History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
  • Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.
  • Subject presently classified as being in New York Heart Association Class IV.
  • Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
  • Known or suspected abuse of alcohol or recreational drugs.
  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Previous participation in this trial. Participation is defined as signed informed consent.
  • Participation in another clinical trial within 90 days before screening.
  • Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
  • Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

• Adults aged 18 years and older
• A diagnosis of obesity (BMI ≥ 27 kg/m2) at screening with self-reported unsuccessful dietary efforts to lose weight.
• No diagnosis of diabetes mellites.
• Able to understand and sign the consent form
• Able to undergo DEXA scan.