What side effects are associated with this type of intervention?

Common treatments for obesity, such as liraglutide and semaglutide (GLP-1 receptor agonists), often cause gastrointestinal side effects like nausea and vomiting. Orlistat, a fat absorption inhibitor, can lead to gastrointestinal issues such as oily stools, flatulence, and frequent bowel movements. Other medications like phentermine and topiramate may cause side effects including increased heart rate, insomnia, dry mouth, and constipation. It is important to consider these potential side effects when choosing an obesity treatment.

What prior FDA approvals exist?

Several FDA-approved drugs for obesity treatment target weight management pathways. Orlistat (Xenical) inhibits fat absorption by blocking pancreatic lipase. Phentermine-topiramate (Qsymia) and lorcaserin (Belviq) suppress appetite through central nervous system mechanisms. Liraglutide (Saxenda) and semaglutide (Wegovy) are GLP-1 receptor agonists that enhance metabolism and reduce appetite. These treatments align with the mechanisms likely being studied in the K-757 trial, which may involve appetite suppression, metabolism enhancement, or fat absorption inhibition.

What other types of research exist?

Promising novel alternatives to K-757 for obesity treatment include: 1) Ghrelin receptor antagonists, which block orexigenic signals and may effectively reduce appetite and promote weight loss. 2) GLP-1 analogues like S 23521, which have shown efficacy in reducing food intake and body weight gain in preclinical studies. 3) Combination therapies involving agents like orlistat and cognitive behavioral therapy, which have been effective in treating binge eating disorder and may benefit obesity patients. 4) Investigational agents targeting the PI3K/PTEN/AKT/mTOR pathway, such as temsirolimus, which regulate metabolism and cellular growth.

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K-757 + K-833 for Obesity

Q: What is the mechanism of action of this treatment?

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.

Phase 2

Waitlist Available

Research Sponsored by Kallyope Inc.

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 15 weeks

Awards & highlights

Study Summary

This trial tests a new drug to see if it safely helps people lose weight.

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.Check my eligibility

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.See study design

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 ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change from baseline in body weight (%) after 13 weeks of treatment

Secondary outcome measures

Change from baseline in body weight (kg) after 13 weeks of treatment

Proportion of participants who discontinued study medication due to an AE

Proportion of participants who experienced 1 or more treatment-emergent AEs

+1 more

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 K-833

2023

Completed Phase 2

~240

K-757 and matching placebo to K-833

2023

Completed Phase 2

~150

Matching placebo to K-757 and matching placebo to K-833

2023

Completed Phase 2

~210

Do I qualify?Apply below to find out

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.

Find a Location

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

~90 spots leftby May 2025

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