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Anti-diabetic agents

K-757 and K-833 combination for Obesity

Phase 1
Recruiting
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 days 1, 28, 42
Awards & highlights

Study Summary

This trial will test how safe and well-tolerated two medications, K-757 and K-833, are when given together to overweight or obese patients with Type 2 diabetes.

Who is the study for?
This trial is for overweight or obese individuals who have Type 2 diabetes. Specific details about who can join are not provided, but typically participants need to meet certain health criteria and agree to follow the study procedures.Check my eligibility
What is being tested?
The study is testing the effects of two drugs, K-757 and K-833, on patients with Type 2 diabetes when taken once (QD) or twice a day (BID). It also includes placebo groups that receive non-active treatments for comparison.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones in diabetes medication trials may include low blood sugar levels, digestive issues, skin reactions at injection sites if applicable, and potential kidney or liver function changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 28, 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 28, 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who discontinued study medication due to an AE
Proportion of participants who experienced 1 or more treatment-emergent AEs
Secondary outcome measures
AUC of plasma K-833
Area under the concentration-time curve [AUC] of plasma K-757
Cl of plasma K-833
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: K-757 and K-833 combinationExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

Kallyope Inc.Lead Sponsor
3 Previous Clinical Trials
234 Total Patients Enrolled
3 Trials studying Obesity
234 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical trial?

"Individuals aged between 18 and 70 with a diagnosis of type 2 diabetes are eligible for enrollment in this research study, which aims to recruit approximately 32 participants."

Answered by AI

What are the risks associated with using a combination of K-757 and K-833 for individuals?

"Given the preliminary nature of this trial as a Phase 1 study, the safety evaluation for the K-757 and K-833 combination has been rated at level 1 by our team."

Answered by AI

What is the primary aim of conducting this clinical investigation?

"The main objective of this research, to be assessed within a period extending Up to Day 43 +/- 2 days, is the percentage of participants who halt the study medication due to an adverse event. Secondary goals encompass determining plasma K-757 Clearance [Cl] when used alongside K-833, Time at which plasma K-757 reaches maximum concentration [Tmax] in conjunction with K-833, and Tmax for plasma K-833 in combination with K-757."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"Indeed, the data on clinicaltrials.gov indicates that this particular clinical trial is actively seeking candidates. Initially shared on 12/7/2023 and last revised on 3/5/2024, the study aims to recruit a total of 32 participants from one designated location."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, data available on clinicaltrials.gov indicates that this clinical investigation is currently seeking eligible individuals. Initially published on December 7th, 2023, the trial was last revised on March 5th, 2024. The objective is to recruit a total of 32 patients from one designated site."

Answered by AI

Are individuals younger than 75 years old eligible to participate in this medical investigation?

"Eligible candidates for this research study must fall within the age bracket of 18 to 70 years. Notably, there are a total of 375 investigations catering to individuals below 18 years old and 1764 studies dedicated to those above 65 years of age."

Answered by AI
~11 spots leftby Jul 2024