K-757 + K-833 for Obesity

Recruiting at 21 trial locations

Overseen By Annemarie Vance

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kallyope Inc.

Must not be taking: Antipsychotics, Antidepressants, GLP-1 agonists

Disqualifiers: Diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

155 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications related to weight loss, diabetes, and mental health must not have been used recently, and some medications are prohibited during the trial. It's best to discuss your specific medications with the trial team.

How does the drug K-757 + K-833 for obesity differ from other treatments?

The drug K-757 + K-833 for obesity is unique because it combines two components that may target different mechanisms in the body, potentially offering a novel approach compared to existing drugs like orlistat, lorcaserin, and others that focus on single pathways. This combination could provide a more comprehensive treatment by addressing multiple aspects of obesity management. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Understand the trial procedures and agree to participate by providing written informed consent prior to trial related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

Meet the following requirements:

Is a male who agrees to all of the following:

Exclusion Criteria

Had treatment with any glucose-lowering agent(s) within 90 days before screening.

Participation in an organized weight reduction program (e.g. Weight Watchers) within 90 days of screening.

You have a history of a serious mental health condition other than the one being studied.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive K-757 alone, K-757 in combination with K-833, or placebo for 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• K-757
• K-833

Trial Overview 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.

Participant Groups

Group I: Placebo to K-757 and K-833 Experimental Treatment 1 Intervention

Group II: K-757+K-833 Experimental Treatment 1 Intervention

Group III: K-757 alone Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Kallyope Inc.

Lead Sponsor

Trials

5

Recruited

660+

Findings from Research

Losing just 5% of body weight can lead to significant health improvements, but many individuals struggle to maintain weight loss through diet and exercise alone, highlighting the need for additional treatment options.

As of 2012, two new medications, lorcaserin and phentermine/topiramate, have been approved for long-term obesity treatment, and bariatric surgery is recommended for patients with severe obesity (BMI ≥40 or ≥35 with comorbidities) as a more intensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. Kushner, RF., Apovian, CM., Fujioka, K.[2018]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

Three FDA-approved medications for long-term obesity treatment—sibutramine, orlistat, and rimonabant—have shown significant weight loss benefits in large clinical trials lasting 2 to 4 years, with average weight loss of 8%-10% compared to 4%-6% for placebo.

While all medications have side effects, sibutramine can increase blood pressure and heart rate, orlistat can cause gastrointestinal issues like steatorrhea, and rimonabant generally has a favorable safety profile with mild, self-limited nausea and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. Bray, GA., Ryan, DH.[2018]

Sibutramine, a serotonin/noradrenaline reuptake inhibitor, has been shown to reduce body weight by an average of 4.45 kg compared to placebo, while also improving triglycerides and HDL cholesterol, but it may cause increased heart rate and has contraindications for patients with uncontrolled hypertension or cardiovascular issues.

Orlistat, a pancreatic lipase inhibitor, results in an average weight loss of 2.89 kg and significantly decreases waist circumference and blood pressure, but primarily causes gastrointestinal side effects and should be avoided in patients with chronic malabsorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological therapy of obesity]. Pagotto, U., Vanuzzo, D., Vicennati, V., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Drug treatment of the overweight patient. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Understanding the Mechanism of Action and Clinical Implications of Anti-Obesity Drugs Recently Approved in Korea. [2020]

5. Italy pubmed.ncbi.nlm.nih.gov

[Pharmacological therapy of obesity]. [2018]