Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06918405
Eligibility Criteria:
Inclusion Criteria
Common inclusion criteria for both diabetic and non-diabetic individuals:
* Informed consent will be obtained before any trial-related activities.
* Male or female, aged ≥18 years at the time of signing the informed consent form.
* Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
* Body mass index (BMI):
* ≥30 kg/m² with or without any weight-related comorbidities or
* ≥25-29.9 kg/m² with the presence of at least one of the following weight-related comorbidities (treated or untreated):
* Hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg or currently taking antihypertensive medication).
* Dyslipidemia (treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) \<40 mg/dL (1.0 mmol/L) for men or HDL \<50 mg/dL (1.3 mmol/L) for women).
* Obstructive sleep apnea.
* Cardiovascular disease (more than three months).
* In the investigator's opinion, are well-motivated, capable, and willing to:
* Learn how to self-inject study drug, as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug).
* Inject study drug (or receive an injection from a trained individual if visually impaired or with physical limitations).
* Follow study procedures for the duration of the study, including, but not limited to, following lifestyle advice (for example, dietary restrictions and exercise plan) and maintaining a study diary.
* Male participants:
* Male participants with partners of childbearing potential should be willing to use reliable contraceptive methods throughout the study and for 5 half-lives of the study drug plus 90 days, corresponding to 4 months after the last injection.
* Female participants:
* Female participants not of childbearing potential may participate and include those who are:
* Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis.
* Postmenopausal, defined as either:
* A woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone ≥40 mIU/mL; women in this category must test negative in pregnancy test prior to study entry.
* A woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea.
* A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy.
* Female participants of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
* Test negative for pregnancy at Visit 1 based on a serum pregnancy test.
* If sexually active, agree to use 2 forms of effective contraception, where at least 1 form is highly effective, for the duration of the trial and for 30 days thereafter.
* Not be breastfeeding.
For subjects with T2DM:
* Patients diagnosed with T2DM more than or equal to 180 days prior to the day of screening.
* HbA1c up to 10.0%.
Exclusion Criteria
Common exclusion criteria for both diabetic and non-diabetic individuals:
* Medical criteria:
* Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
* A self-reported reduction in body weight of more than 5 kg within 30 days before screening, irrespective of medical records.
* Treatment with any medication for the indication of obesity within the past 90 days before screening (e.g., Orlistat, liraglutide, naltrexone/bupropion, diethylpropion, phendimetrazine, semaglutide, and setmelanotide).
* Any previous obesity treatment with surgery or a weight loss device during a lifetime.
* Continued treatment with other GLP-1 agonists, SGLT-2 inhibitors, and/or metformin. However, if these drugs can be stopped based on the best clinical judgment of the investigator, the patient can be recruited after stopping the drug and a washout period of two weeks. In the case of tirzepatide, the washout period will be 8 weeks.
* Are receiving or have received within 3 months prior to screening chronic (\>2 weeks or 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis).
* Have current or history of (within 3 months prior to enrollment) treatment with medications that may cause significant weight gain, including but not limited to tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
* Have started implantable or injectable contraceptives (such as Depo-Provera®) within 18 months prior to screening.
* Past history of pancreatitis.
* Diagnosed case of eating disorders (e.g., Bulimia nervosa).
* Patients with a previous history of suicide attempts and major depressive disorder (MDD) according to DSM-V criteria, schizophrenia, or antipsychotic drug-induced obesity.
* Patients with a personal or family history of medullary thyroid carcinoma (MTC) and/or multiple endocrine neoplasia syndrome type 2 (MEN 2).
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
* Have uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg).
* Have NYHA Functional Classification IV CHF.
* Have had a transplanted organ (corneal transplants \[keratoplasty\] allowed) or awaiting an organ transplant.
* Laboratory criteria:
* Incidental diagnosis or uncontrolled thyroid disease, defined as a thyroid-stimulating hormone (TSH) level \>6.0 mIU/L or \<0.4 mIU/L as measured by the central laboratory at screening. However, well-controlled thyroid disorder can be included if TSH \<6.0 or \>0.4 mIU/L.
* Renal impairment, measured as the estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m².
For subjects without T2DM:
\- HbA1c more than or equal to 48 mmol/mol (6.5%).
For subjects with T2DM:
* Renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m² (less than 60 mL/min/1.73 m² in subjects treated with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)).
* Uncontrolled T2DM (HbA1c \>10.0%) as these patients may require insulin or other anti-diabetic drugs which might potentially interfere with the efficacy of tirzepatide.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06918405
Study Brief:
Protocol Section:
NCT06918405