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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing two treatments for obesity: one using a drug called K-757 alone, and another using K-757 with K-833. It aims to see if these treatments can help improve health outcomes in obese participants.
Who is the study for?
This trial is for adults aged 18-70 with obesity (BMI of 30.0 to <40.0) who have been weight stable for the last 3 months and are non-smokers or light smokers. Participants must be willing to follow study procedures, including diet requirements, and use effective contraception during the study. Those with recent weight loss treatments, severe psychiatric disorders, uncontrolled thyroid disease, diabetes mellitus, or using certain medications are excluded.
What is being tested?
The trial is testing K-757 alone and in combination with K-833 against a placebo to see if they're safe and can help people lose weight effectively. Participants will receive either one of these drugs or a placebo in a controlled environment to compare results.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with weight loss drugs may include gastrointestinal issues like nausea or constipation, headaches, dizziness, dry mouth, insomnia and potential changes in mood or blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Group I: Placebo to K-757 and K-833Experimental Treatment1 Intervention
Group II: K-757+K-833Experimental Treatment1 Intervention
Group III: K-757 aloneExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
K-757 and matching placebo to K-833
2023
Completed Phase 2
~150
K-757 and K-833
2023
Completed Phase 2
~240
Matching placebo to K-757 and matching placebo to K-833
2023
Completed Phase 2
~210
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity often target three main pathways: appetite suppression, metabolism enhancement, and fat absorption inhibition. Appetite suppressants work by affecting neurotransmitters in the brain to reduce hunger, leading to lower calorie intake.
Metabolism enhancers increase the body's energy expenditure, helping to burn more calories even at rest. Fat absorption inhibitors prevent the digestive system from absorbing a portion of the fat consumed, reducing overall calorie intake.
These mechanisms are crucial for obesity patients as they address the fundamental issues of excessive calorie intake and insufficient calorie expenditure, thereby aiding in effective weight management.
Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?Pharmacotherapy of obesity: emerging drugs and targets.
Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?Pharmacotherapy of obesity: emerging drugs and targets.
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Who is running the clinical trial?
Kallyope Inc.Lead Sponsor
3 Previous Clinical Trials
116 Total Patients Enrolled
3 Trials studying Obesity
116 Patients Enrolled for Obesity
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