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Tests treatment safety and results for Obesity
Official title Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
ClinicalTrials.gov ID: NCT07497880
What this study is testing
What is KAI-7535?
KAI-7535 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous...
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease
You likely can't join if
- For participants without diabetes:
- Laboratory evidence of diabetes
- Taking a concomitant medication for the indication of glycemic control
- For participants living with type 2 diabetes mellitus only:
- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
See the full eligibility criteria
- For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease
- For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only:
- Diagnosis of type 2 diabetes mellitus
- On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening Key
- For participants without diabetes:
- Laboratory evidence of diabetes
- Taking a concomitant medication for the indication of glycemic control
- For participants living with type 2 diabetes mellitus only:
- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
- History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
- Started medications that may cause significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to screening
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma
- Uncontrolled hypertension or unstable cardiovascular disease
- History of chronic or acute pancreatitis
- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable major depressive disorder or other severe psychiatric disorder
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Irvine, California, United States
- Lincoln, California, United States
- Northridge, California, United States
- Hamden, Connecticut, United States
- Jacksonville, Florida, United States
- Jupiter, Florida, United States
- Pembroke Pines, Florida, United States
- Decatur, Georgia, United States
- Skokie, Illinois, United States
- South Bend, Indiana, United States
- Kenner, Louisiana, United States
- Garden City, Michigan, United States
- Jefferson City, Missouri, United States
- Kansas City, Missouri, United States
- Spartanburg, South Carolina, United States
- Knoxville, Tennessee, United States
- Austin, Texas, United States
- Brownsville, Texas, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Irvine, California, United States; Lincoln, California, United States; Northridge, California, United States; Hamden, Connecticut, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.