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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06019559

Run by

Kallyope Inc.

People needed

155

Starts

2023-09-15

Expected to finish

2024-02-19

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
• OR
• 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.
• OR
• Is a female of reproductive potential and:
• agrees to not donate eggs from the first dose of study drug until 14 days after the last dose of study drug.
• agrees to remain abstinent from heterosexual activity or
• agrees to use (or have their partner use) a birth control method that is highly effective and has low user dependency from the first dose of study drug until 14 days after the last dose of study drug. Acceptable methods of birth control are:
• Progestogen-only implant (e.g. etonogestrel implant)
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion

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 clinically significant endocrine disease including T2DM. Note: A history of hypothyroidism does not require exclusion if the subject has been on a stable dose of thyroid hormone replacement (thyroxine) for at least 3 months prior to screening and the screening thyroid-stimulating hormone (TSH) is within the central laboratory normal range.
• 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.
• Had a previous or has a planned (during the trial period) obesity treatment with surgery or a weight loss device. Note: Prior liposuction and/or abdominoplasty are not exclusionary if performed >2 years before 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.
• any anti-depressant drug-treatment regimens (medications and doses) have been stable for ≥6 months prior to screening.
• Has any history of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) that was not clearly attributable to an intercurrent event/life circumstance, self-limited and fully resolved ≥1 year prior to screening.
• On the screening Patient Health Questionnaire-9 (PHQ-9), has an overall score ≥15 or has a score >0 for Question # 9 (Thoughts that you would be better off dead or of hurting yourself).
• Has any lifetime history of suicide attempt or suicidal behavior. Note: Suicidal behavior includes any acts/preparation toward making a suicide attempt whether the attempt is never initiated or is initiated but interrupted by self or another person.
• Use of any anti-psychotic agents for any purpose within 2 years before screening.
• Use of prohibited classes of anti-depressant agents, for any purpose, within 6 months of screening. Note: Use of allowable classes of anti-depressant agents is permitted only if the anti-depressant regimen (agents and doses) has been stable for ≥6 months prior to screening and is not anticipated to change during the trial period.
• General Safety:
• Has a recent history (within the past 3 years of the screening visit) or current diagnosis of clinically significant hematological, immunological, renal, respiratory, neurologic, or genitourinary abnormalities or diseases.

Where it is running

• Artemis Institute for Clinical Research, LLC — San Diego, California, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• ActivMed Practices and Research, LLC — Portsmouth, New Hampshire, United States
• Rochester Clinical Research — Rochester, New York, United States
• Medication Management, LLC (PharmQuest) — Greensboro, North Carolina, United States
• Wilmington Health (Accellacare of Wilmington) — Wilmington, North Carolina, United States
• Family Practice Center of Wadsworth, Inc dba New Venture Medical Research — Wadsworth, Ohio, United States
• AMR Norman — Norman, Oklahoma, United States
• Summit Headlands LLC — Portland, Oregon, United States
• Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
• Reading Hospital Clinical Trials Office — West Reading, Pennsylvania, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Headlands Research - Brownsville — Brownsville, Texas, United States
• North Hills Family Medicine/North Hills Medical Research — North Richland Hills, Texas, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States
• Washington Center for Weight Management and Research, Inc. — Arlington, Virginia, United States
• Charlottesville Medical Research — Charlottesville, Virginia, United States
• Health Research of Hampton Roads, Inc — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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