A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes

NCT06305351 | Completed Phase 1 FDA Drug

• 1 other identifier: K-757 P008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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 diabetes mellitus (T2DM)

Conditions

Obesity; Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (2)

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

  Up to Day 43 +/- 2 days

• Proportion of participants who discontinued study medication due to an AE

  Up to Day 43 +/- 2 days

Secondary Outcomes (12)

• Area under the concentration-time curve [AUC] of plasma K-757

  Days 1, 28, 42

• AUC of plasma K-833

  Days 1, 28, 42

• Maximum concentration [Cmax] of plasma K-757

  Days 1, 28, 42

• Cmax of plasma K-833

  Days 1, 28, 42

• Time of maximum concentration [Tmax] of plasma K-757

  Days 1, 28, 42

Study Arms (2)

K-757 and K-833 combination

EXPERIMENTAL

Drug: K-757 and K-833 QD; Drug: K-757 and K-833 BID

Placebo

PLACEBO COMPARATOR

Drug: Matching placebo to K-757 and K-833 QD; Drug: Matching placebo to K-757 and K-833 BID

Interventions

K-757 and K-833 QD DRUG

Both administered orally once daily

K-757 and K-833 combination

K-757 and K-833 BID DRUG

Both administered orally twice daily

K-757 and K-833 combination

Matching placebo to K-757 and K-833 QD DRUG

Both administered orally once daily

Placebo

Matching placebo to K-757 and K-833 BID DRUG

Both administered orally twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the trial procedures and agree to participate by providing written informed consent.
• Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements.
• Be between 18 to 70 years of age, inclusive, at the Screening Visit.
• Has T2DM in accordance with American Diabetes Association (ADA) guidelines at the Screening Visit.
• Is on stable metformin monotherapy (total daily dose of 1,000 to 2,000 mg/day) for at least 3 months and tolerating metformin well in the opinion of the investigator. Note: Both the immediate release (IR) and extended release (XR) formulations of metformin are acceptable.
• HbA1c of ≤7.5% at Screening.
• Have a Body Mass Index (BMI) ≥25.0 and \<40.0 (kg/m2) at the Screening Visit.
• Be weight stable (\<5% variation) over the last 3 months, by subject report.
• Be a nonsmoker who has not used tobacco or nicotine-containing products (e.g. nicotine patch, e-cigarettes, vapes) for at least 3 months before administration of the initial dose of trial drug and agrees to abstain from smoking tobacco or the use of nicotine-containing products while on study.
• Be judged to be in generally good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug.
• Meet the following requirements:
• Is a male who agrees to all of the following:
• If partner is a non-pregnant female of child-bearing potential: To use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until 14 days after the last dose of study drug. A male subject who has had a vasectomy procedure must use a condom but is not required to use spermicidal cream or jelly.
• If partner is pregnant, to use a condom. Note: Contraception/condom requirements are waived if partner is NOT of child-bearing potential (i.e. is male or is a female who is post-menopausal or surgically sterile \[post-hysterectomy, post-bilateral oophorectomy, and/or post-bilateral salpingectomy\]).
• To not donate sperm from the first dose of study drug until 14 days after the last dose of study drug.

You may not qualify if:

• Has participated in another interventional investigational study within 30 days of the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study. If the subject received an investigational medication in the prior study, at least 5 half-lives (or longer if required by local regulations) must have passed between the last dose of the investigational product and the Screening Visit.
• Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
• Has a history of multiple significant and/or any severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
• Has a known hypersensitivity or contraindication to any component of K-757, K-833, including excipients.
• Has a positive alcohol or drug screen at Screening or admission.
• Has a positive pregnancy test.
• Is a lactating/nursing female.
• Has a positive test result for hepatitis B surface antigen (Ag), hepatitis C virus antibody, or human immunodeficiency (HIV) antibody, at the Screening Visit. Note: Subjects with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
• Does not meet study site COVID-19 admission/study participation restrictions.
• Has a fever (\>38°C)\*
• Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit\*
• Is unable to refrain from the use of prohibited prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication through completion of study participation.
• Allowable concomitant medications may include 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), ≤2 permissible anti-hypertensive agents, postmenopausal hormone replacement therapy (HRT), and/or proton pump inhibitors (PPIs).
• Has been on any GLP-1 receptor agonist, any dipeptidyl peptidase IV (DPP-4) inhibitor, or any approved or investigational medications known to cause weight loss in the prior 3 months.
• Has a history of type 1 diabetes mellitus (T1DM) or a history of diabetic ketoacidosis or subject assessed by the investigator as possibly having T1DM.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (1)

QPS Miami

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: December 7, 2023
• Primary Completion: May 15, 2024
• Study Completion: June 21, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

US (1)