A Study to Investigate the Safety and Efficacy of TE-8105 in Overweight or Obesity Participants

Korábbi kezelés

• Previous weight-loss surgery or procedures (e.g., gastric bypass, sleeve gastrectomy, gastric balloon, or intestinal sleeve) within 6 months prior to screening, or planned during the study.
• Participation in organized weight-loss programs (e.g., WeightWatchers, Jenny Craig) or meal replacement plans within 30 days prior to screening or planned during the study.
• Self-reported weight change of more than 5% in the 6 months prior to randomization or more than 10% in the 12 months prior to screening.
• Exposure to any GLP-1 receptor agonist medications within 3 months prior to screening, history of allergic reactions to GLP-1 medications, or lingering effects/rebound weight gain from past GLP-1 treatments.
• Use of prescription or over-the-counter medications intended to promote weight loss or that cause weight gain within 3 months prior to randomization.
• Severe or uncontrolled heart conditions within 3 months prior to randomization (e.g., heart attack, stroke, unstable angina, or heart failure hospitalization), or Class IV severe heart failure.
• Active infection requiring systemically absorbed antibiotics, antivirals, or antifungals within 10 days before the first dose.
• Any lifetime history of suicide attempts, or active suicidal thoughts/self-harm ideation within 2 weeks prior to or during screening.
• Positive drug screen for drugs of abuse or positive alcohol breath test at screening or before the first dose.
• Unwillingness to refrain from starting new intense exercise programs (including weightlifting) from 7 days prior to Day 1 through 28 days after the final dose.
• Unwillingness to follow dietitian advice, maintain study diaries, or refrain from using prohibited medications.
• Blood or plasma donation within 30 days, major blood loss (>500 mL) within 30 days, or blood transfusion within 1 year prior to first dose.
• Participation in another clinical trial testing an investigational drug or device within 30 days prior to screening.

Más betegség

• Use of any diabetes medication other than metformin (e.g., insulin use is excluded).
• Diagnosis of Type 1 diabetes, history of diabetic ketoacidosis, or hyperosmolar coma.
• Obesity caused by other hormonal disorders (e.g., Cushing syndrome) or rare genetic conditions (e.g., Prader-Willi syndrome).
• History or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN 2).
• Uncontrolled thyroid disease, unless on a stable thyroid replacement dose for at least 3 months, or subclinical thyroid conditions that may require new treatment during the study.
• History of chronic pancreatitis or unexplained acute pancreatitis.
• Gastrointestinal disorders (such as severe acid reflux or delayed stomach emptying) that could interfere with drug absorption or study participation.
• Active cancer or history of cancer within the last 10 years (except fully removed non-melanoma skin cancer).
• Positive screening test for HIV, Hepatitis B, or Hepatitis C.
• Active or unstable major depression or severe psychiatric disorders (such as schizophrenia or bipolar disorder) within the past 2 years. (Participants with stable depression or generalized anxiety on stable treatment may be eligible).
• History of alcohol abuse within 1 year, or regular consumption of more than 2 standard drinks per day (14 drinks per week).
• Skin conditions (such as severe sunburn, deep scar tissue, large tattoos, or open sores) at potential injection sites that would interfere with dosing or site assessments.
• Any active, serious medical condition with an estimated life expectancy of less than 2 years, or any condition that in the investigator's judgment makes participation unsafe or non-compliance likely.

Laborértékek

• An abnormal clinical laboratory test value specified in the protocol.
• Severe kidney impairment (eGFR <30 mL/min/1.73 m² or creatinine clearance <60 mL/min).
• Significant liver disease, acute/chronic hepatitis, elevated liver enzymes (ALT > 3.0x upper limit of normal, ALP >1.5x upper limit of normal, or bilirubin >1.2x upper limit of normal), or fasting triglycerides > 500 mg/dL.
• History of irregular heart rhythms or risk factors for long QT syndrome (Torsade de Pointes).

Egyéb

• Heavy smoking or nicotine use (≥6 cigarettes, cigars, vapes, or nicotine equivalents per day).
• Females who are pregnant, breastfeeding, or planning to breastfeed.

• Able to understand the full nature, purpose, and risks of the study and provide written informed consent before starting study procedures.
• Body Mass Index (BMI) ≥25 and ≤34.9 kg/m², OR
• BMI ≥25 and ≤34.9 kg/m² with at least one weight-related condition: high blood pressure (hypertension), high cholesterol or triglycerides (dyslipidemia), cardiovascular disease, or type 2 diabetes mellitus.
• Stable body weight (less than 5% change in weight in either direction) during the screening period.
• Medically healthy overall (apart from overweight or obesity) as determined by medical history, physical examination, vital signs, ECG, and routine laboratory tests without clinically significant abnormalities.
• Female participants:
  • Must be unable to become pregnant (postmenopausal for at least 12 months or surgically sterilized at least 6 weeks prior to screening), OR
  • If able to become pregnant: must have negative pregnancy tests at screening and before randomization, agree not to attempt pregnancy or donate eggs, and agree to use a condom combined with a highly effective method of birth control from consent until at least 60 days after the last study dose (unless practicing complete abstinence or in a same-sex relationship).
• Male participants:
  • Must agree not to donate sperm from consent until at least 120 days after the last study dose.
  • If sexually active with a female partner who can become pregnant, must agree to use a condom combined with highly effective birth control until at least 120 days after the last study dose.
  • If sexually active with a female partner who cannot become pregnant or a same-sex partner, must agree to use a condom until at least 30 days after the last study dose.
• Have suitable veins for routine blood draws.