K-757 + K-833 for Obesity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, K-757 alone and in combination with K-833, to evaluate their safety and effectiveness for individuals with obesity. Participants will receive either the treatments or a placebo (a harmless, inactive substance) for comparison. It is ideal for those who have struggled with weight loss through dieting, have maintained a stable weight recently, and do not have certain health conditions like diabetes or significant mental health issues. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that K-757 and K-833 have been tested both together and separately for human safety. In one study, these treatments were administered to overweight and obese individuals with Type 2 diabetes. The study assessed drug tolerance and found that participants generally tolerated them well.

Another study focused solely on K-757. After 13 weeks, participants taking K-757 alone lost 1.6% of their body weight, suggesting the drug's effectiveness without major issues.

In a separate study, combining K-757 with K-833 led to a 2.9% weight loss in participants. This combination was also well-tolerated, indicating that both drugs can work together safely.

These studies provide evidence that K-757 and K-833 are safe for people, but further research is ongoing to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about K-757 and K-833 for obesity because they offer a fresh approach compared to typical treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Unlike existing options that mainly suppress appetite or inhibit fat absorption, K-757 and K-833 may work by targeting specific metabolic pathways to enhance energy expenditure and reduce fat accumulation. This novel mechanism could potentially lead to more effective and sustained weight loss outcomes, providing hope for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will evaluate the effectiveness of K-757 alone and in combination with K-833 for weight loss. Research has shown that using K-757 and K-833 together can lead to noticeable weight loss. In one study, participants taking this combination lost 2.94% of their body weight in 13 weeks, while those on a placebo lost only 0.15%. K-757 alone also aids in weight loss, resulting in a 1.42% reduction, though it is less effective than when combined with K-833. These treatments activate certain parts of the body that help control weight and blood sugar. Overall, using K-757 and K-833 together appears to be a more effective weight loss strategy than using K-757 alone. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

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biospace.com

biospace.com/drug-development/kallyope-discreetly-drops-disappointing-data-for-oral-obesity-candidate

Kallyope Discreetly Drops Disappointing Data for Oral ...

Combining K-757 with K-833, however, elicited a significant 2.94% drop in weight at 13 weeks. Those on placebo lost only 0.15% body weight over ...

2.

kallyope.com

kallyope.com/kallyope-enters-phase-2-with-first-in-class-oral-approach-for-the-treatment-of-both-obesity-and-type-2-diabetes-2/

Kallyope Enters Phase 2 With First-in-class Oral Approach ...

The trial, K-757 P006, aims to demonstrate the weight-loss efficacy, safety, and tolerability of these novel agents for patients with obesity, a ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40767101/

Combined GPR40 and GPR119 full agonism with K-757 ...

Combined GPR40 and GPR119 full agonism with K-757 and K-833 results in robust glucose lowering and modest weight loss in overweight/obese ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05890950

NCT05890950 | A Study to Evaluate the Safety, ...

This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 ...

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dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.70014

Combined GPR40 and GPR119 full agonism with K‐757 and ...

Combined GPR40 and GPR119 full agonism with K-757 and K-833 results in robust glucose lowering and modest weight loss in overweight/obese ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05900531

NCT05900531 | A Study to Evaluate the Safety, Tolerability ...

This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 alone, in combination with sitagliptin, or in combination with K-833.

7.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-evaluate-the-safety-tolerability-and-weight-loss-efficacy-of-k-757-alone-and-in-combina

A Study to Evaluate the Safety, Tolerability, and Weight Loss ...

This is a study to evaluate the safety and efficacy of K-757 alone and in combination with K-833 versus placebo in participants who are ...

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synapse.patsnap.com

synapse.patsnap.com/drug/75ecd6c78a20430385b49a4d55cfe099

K-757 - Drug Targets, Indications, Patents

After 13 weeks of treatment, patients given K-757 monotherapy lost 1.6% of their body weight, the database update reveals, and those in the combo arm lost 2.9%.