A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833

NCT06019559 | Completed Phase 2 Results FDA Drug

• 1 other identifier: K-757 P006
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 22

Brief Summary

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 obese.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment

  13 weeks

Secondary Outcomes (4)

• The Proportion of Participants Achieving ≥5% Weight Loss After 13 Weeks of Treatment

  13 weeks

• Absolute Change From Baseline in Body Weight (kg) After 13 Weeks of Treatment

  13 weeks

• Proportion of Participants Who Experienced 1 or More Treatment-emergent AEs

  15 weeks

• Proportion of Participants Who Discontinued Study Medication Due to an AE

  13 weeks

Study Arms (3)

K-757+K-833

EXPERIMENTAL

Drug: K-757 120 mg BID and K-833 100 mg BID

K-757 alone

EXPERIMENTAL

Drug: K-757 120 mg BID and matching placebo to K-833

Placebo to K-757 and K-833

EXPERIMENTAL

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

Interventions

K-757 120 mg BID and K-833 100 mg BID DRUG

K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22. K-833 was initiated at 100 mg once daily in the morning (QAM) and was titrated to the maintenance dose of 100 mg BID on Day 8. Both administered orally.

K-757+K-833

K-757 120 mg BID and matching placebo to K-833 DRUG

K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22. Both administered orally.

K-757 alone

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

Both administered orally.

Placebo to K-757 and K-833

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 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.
• Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions, including following study diet requirements.
• Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent.
• Have a body mass index (BMI) of 30.0 to \<40.0. kg/m2, inclusive.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
• Be weight stable (\<5% variation) over the last 3 months (by subject report).
• Be a nonsmoker or has smoked ≤10 cigarettes per week for at least 3 months and agrees not to exceed this for the duration of study participation; has not used other nicotine containing products (e.g. other forms of tobacco, nicotine patch, e cigarettes, vapes) for at least 3 months and agrees to abstain from such products throughout study participation.
• Meet the following requirements:
• Is a male who agrees to all of the following:
• To use an appropriate method of contraception, including a condom which must include 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 in the menopausal range established for the central laboratory.
• Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history.

You may not qualify if:

• Glycemia related:
• Has a hemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) as measured by the central laboratory at screening.
• Has a history of type 1 or type 2 diabetes mellitus.
• Had treatment with any glucose-lowering agent(s) within 90 days before screening.
• Obesity related:
• Had treatment with any medication approved for the treatment of obesity or any investigational agent being tested for obesity treatment within the past 6 months before screening.
• Has been treated with/used any other medication, supplement, or device for the purpose of promoting weight loss (regardless of whether they are approved or promoted for the purpose of weight loss) in the 90 days prior to screening.
• Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist in the prior 6 months.
• Participation in an organized weight reduction program (e.g. Weight Watchers) within 90 days of screening.
• Has uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) outside (above or below) the reference range of the central laboratory at screening or has any history of Grave's disease.
• Obesity is induced by an endocrine disorder (e.g. Cushing's disease).
• Mental health:
• Has a history of major depressive disorder within 2 years before screening unless all of the following criteria are met:
• the depressive disorder has always been unipolar (no history of mania or hypomania)
• in the opinion of the investigator, depressive symptoms have been stable and well controlled for ≥ 2 years prior to screening.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (22)

Artemis Institute for Clinical Research, LLC

San Diego, California, 92103, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

ActivMed Practices and Research, LLC

Portsmouth, New Hampshire, 01844, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Medication Management, LLC (PharmQuest)

Greensboro, North Carolina, 27408, United States

Location

Wilmington Health (Accellacare of Wilmington)

Wilmington, North Carolina, 28401, United States

Location

Family Practice Center of Wadsworth, Inc dba New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

AMR Norman

Norman, Oklahoma, 73069, United States

Location

Summit Headlands LLC

Portland, Oregon, 97210, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Reading Hospital Clinical Trials Office

West Reading, Pennsylvania, 19611, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Headlands Research - Brownsville

Brownsville, Texas, 78526, United States

Location

North Hills Family Medicine/North Hills Medical Research

North Richland Hills, Texas, 76180, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Washington Center for Weight Management and Research, Inc.

Arlington, Virginia, 22206, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Health Research of Hampton Roads, Inc

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Director
• Organization: Kallyope Inc

contactus@kallyope.com

917-336-3279

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: September 15, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 19, 2024
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Locations

US (22)