A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers

NCT05900531 | Completed Phase 1 FDA Drug

• 1 other identifier: K-757 P004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (2)

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

  after treatment with K-757 administered alone, when co-administered with sitagliptin, and when co-administered with K-833

  Up to Day 42 +/- 2 days

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

  after treatment with K-757 administered alone, when co-administered with sitagliptin, and when co-administered with K-833

  Up to Day 42 +/- 2 days

Secondary Outcomes (24)

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

  Days 1 and 28

• Maximum concentration [Cmax] of plasma K-757

  Days 1 and 28

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

  Days 1 and 28

• Clearance [Cl] of plasma K-757

  Days 1 and 28

• Volume of distribution at steady-state [Vdss] of plasma K-757

  Days 1 and 28

Study Arms (10)

K-757 (Panel A)

EXPERIMENTAL

Drug: K-757

K-757 (Panel B)

EXPERIMENTAL

Drug: K-757

K-757 + sitaglipitin (Panel C)

EXPERIMENTAL

Drug: K-757 and open-label sitagliptin

K-757 and K-833 (Panel D)

EXPERIMENTAL

Drug: K-757 and K-833

K-757 and K-833 (Panel E)

EXPERIMENTAL

Drug: K-757 and K-833

Panel A

PLACEBO COMPARATOR

Drug: Matching placebo to K-757

Panel B

PLACEBO COMPARATOR

Drug: Matching placebo to K-757

Panel C (+ sitagliptin)

PLACEBO COMPARATOR

Drug: Matching placebo to K-757, open-label sitagliptin

Panel D

PLACEBO COMPARATOR

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

Panel E

PLACEBO COMPARATOR

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

Interventions

K-757 DRUG

administered orally

K-757 (Panel A); K-757 (Panel B)

K-757 and open-label sitagliptin DRUG

both administered orally

K-757 + sitaglipitin (Panel C)

Matching placebo to K-757 DRUG

administered orally

Panel A; Panel B

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

both administered orally

Panel D; Panel E

K-757 and K-833 DRUG

both administered orally

K-757 and K-833 (Panel D); K-757 and K-833 (Panel E)

Matching placebo to K-757, open-label sitagliptin DRUG

both administered orally

Panel C (+ sitagliptin)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• l. 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 healthy between 18 to 60 years of age, inclusive, at the Screening Visit.
• \. Have a Body Mass Index (BMI) ≥27.0 and \<35.0 (kg/m2) at the Screening Visit.
• \. Be weight stable (\<5% variation) over the last 3 months.
• \. 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 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:
• To use an appropriate method of contraception, including a condom with or without 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 had a vasectomy procedure must follow the same restrictions as a non-vasectomized man.
• If partner is pregnant, to use a condom
• To not donate sperm from the first dose of study drug until 14 days after the last dose of study drug.
• Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
• Postmenopausal (aged \>45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level \>30 mIU/mL).
• Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history.

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 (e.g., 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 (all Panels), sitagliptin (Panel C only), or K-833 (Panels D and E only), related compounds or their 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 are limited to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), ≤2 permissible anti-hypertensive agents, and post-menopausal hormone replacement therapy (HRT). Statin doses must have been stable with reported compliance of at least 80% for ≥3 months prior to the Screening Visit. Anti-hypertensive and HRT doses/regimens must have been stable for ≥1 month prior to the Screening Visit.
• 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 excessive consumption of alcohol within 6 months prior to screening (\>14 drinks/week for men and \>7 drinks/week for women, where l drink= 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening.
• Is unwilling or unable to refrain from consuming alcohol from 7 days prior to the first dose of study medication through the completion of study participation.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (1)

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: June 12, 2023
• Study Start: September 21, 2022
• Primary Completion: May 3, 2023
• Study Completion: May 31, 2023
• Last Updated: November 22, 2024

Record last verified: 2023-05

Locations

US (1)