A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes

Korábbi kezelés

• Have attended any weight loss treatment or program (e.g., bariatric surgery, medication) within the 3 months prior to Screening, or have scheduled any weight loss treatment or program within the study period.
• Have had any exposure to GLP-1 analogs or other related compounds within the 3 months prior to Screening, or have a history of allergies to glucagon-like peptide-1 (GLP-1) analogs or related compounds.
• Unwilling to refrain from commencing any new strenuous exercise programs (including weightlifting) from 7 days prior to admission to the study site until 28 days after the final dose.
• Males must use an acceptable, highly effective double contraception from Screening until study completion and must not donate sperm until at least 90 days after the last dose of study drug.

Más betegség

• Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), a history of ketoacidosis, or hyperosmolar state/coma.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have had a history of chronic pancreatitis or idiopathic acute pancreatitis.
• Have GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease that impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, except appendectomy) or could be aggravated by GLP-1 analogs.
• Have obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).

Laborértékek

• History of kidney dialysis or renal impairment measured as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² at Screening.

Egyéb

• Anything that the PI considers that would jeopardize the safety of the participant, or prevent complete participation in the study, or compromise the interpretation of study data.
• Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion.

• Adults who are overweight or obese, do not have diabetes, and who are otherwise healthy, will be recruited. Main inclusion / exclusion criteria include but are not limited to:
• Male or female between 18 and 65 years old (both inclusive, at the time of informed consent).
• Have a BMI of ≥ 25 and ≤ 34.9 kg/m² or ≥ 23 and ≤ 32.5 kg/m² for Asian and Aboriginal participants.
• Have a stable body weight, defined as < 5% change in body weight, in either direction, during the Screening period (Day -28 to Day -1).
• Hemoglobin A1C (HbA1c) < 6.5%.
• Able and willing to provide written informed consent and any locally required authorization before performing any protocol-related procedures, including screening evaluations.