Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Obesity
• Age: Between 18 Year(s) - 80 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Signed informed consent before any study-related activities are initiated, must be able to understand the full nature and purpose of the trial (including possible risks and adverse effects), and be willing to comply with all study procedures and adhere to the protocol schedule and restrictions.
  2. Men and women, age ≥18 years and <80 years, with:
     • BMI ≥30 kg/m2 or
     • BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥1 comorbidity:
     • Hypertension.
     • Dyslipidemia or receiving treatment with an approved lipid lowering medication.
     • Documented obstructive sleep apnea or receiving treatment for obstructive sleep apnea.
     • Cardiovascular disease, including documented coronary artery atherosclerotic disease, peripheral arterial atherosclerotic disease, stroke, or transient ischemic attacks.
     • Documented diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) (confirmed by clinical, laboratory, imaging, or biopsy findings)
  3. Screening HbA1c <6.5%.
  4. Reproductive status:
     • Female participants of nonchildbearing potential.
     • Female participants of childbearing potential must have a negative urine pregnancy test at the Screening visit and a negative urine pregnancy test (or confirmatory negative serum pregnancy test) during Screening and Day 1. Additionally, they must not be or plan to be breastfeeding, must agree not to donate ova, not attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception from the time of signing the informed consent form (ICF) until ≥30 days after the last dose of the study drug.
     • Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a highly effective method of contraception from signing the ICF until ≥90 days after the last dose of study drug.

  
  

You may not be eligible for this study if the following are true:

• 1. Previous documented diagnosis of diabetes (except for gestational diabetes and the participant has an HbA1c <6.5%).
  2. Self-reported change in body weight >5% within 3 months before Screening.
  3. Body weight ≤80 kg at Screening.
  4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening).
  5. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal- jejunal endoluminal liner.
  6. Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency).
  7. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months.
  8. History of treatment for cancer in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma, in situ cervical cancer, or in situ prostate cancer).
  9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
  10. History of chronic pancreatitis or idiopathic acute pancreatitis, or documented history of biliary stones. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has a cholecystectomy to resolve the problem.
  11. Chronic malabsorption, regardless of etiology.
  12. History of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease.
  13. Documented diagnosis of heart failure and at Screening New York Heart Association Class III or IV.
  14. Within the past year before the Screening visit, any of the following: episode of acute coronary event, transient ischemic attack, stroke, peripheral arterial vascular disease leading to revascularization, or other significant cardiovascular event.
  15. A seated blood pressure (BP) after resting for 5 minutes >160 mm Hg systolic or >100 mm Hg diastolic.
  16. An apical (brachial is acceptable) pulse rate >100 beats per minute. If elevated, the measurements may be repeated 2 more times and the average of all 3 measurements used to determine eligibility.
  17. Documented diagnosis of cirrhosis.
  18. Presence or having sequelae of GI, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  19. Any history of ileus.
  20. Positive test results for an active viral infection: severe acute respiratory syndrome coronavirus 2, human immunodeficiency virus (HIV)-1 or HIV-2 with positive antibodies, hepatitis B virus with a positive hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) with positive antibodies and viral load at the Screening visit.
  21. Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.
  22. Have a lifetime history of suicide attempt.
  23. Use of medications intended to promote weight loss, within 6 months prior to Screening.
  24. Have current treatment with or history of treatment with (within 3 months prior to Screening) medications that may cause significant weight gain including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
  25. Use of strong CYP3A4 inducers or moderate to strong CYP3A4 inhibitors, drugs that are P-gp or BCRP substrates, or drugs that are P-gp inducers or P-gp inhibitors.
  26. History of substance abuse within 12 weeks before Screening.
  27. Participants recovering from opiate abuse, taking methadone or buprenorphine/naloxone (Suboxone®).
  28. Positive drugs of abuse screen (excluding marijuana [tetrahydrocannabinol (THC)]) before the first dose of study drug.
  29. Are currently enrolled in any other clinical study or have participated in another clinical trial of an investigational drug or device targeting a weight reduction therapy within 60 days before the first study drug administration.
  30. Pregnant, breastfeeding, or intends to become pregnant.
  31. Consumption of grapefruit, tangelo, or Seville orange (or products containing grapefruit, tangelo, or Seville orange) within 10 days before the first administration of study drug and throughout the study.
  32. Known hypersensitivity to any of the study drug ingredients.