Mode
Text Size
Log in / Sign up
Phase 2 Completed N=155 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT06019559 ↗
Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment — -0.15; -1.57; -2.94 % Change from Baseline — p=0.0756

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment
-0.15; -1.57; -2.94 0.0756
SECONDARY
The Proportion of Participants Achieving ≥5% Weight Loss After 13 Weeks of Treatment
6; 9; 11 0.8366
SECONDARY
Absolute Change From Baseline in Body Weight (kg) After 13 Weeks of Treatment
-0.09; -1.64; -3.11 0.0616
SECONDARY
Proportion of Participants Who Experienced 1 or More Treatment-emergent AEs
31; 41; 42
SECONDARY
Proportion of Participants Who Discontinued Study Medication Due to an AE
2; 9; 14

Eligibility Criteria

Inclusion Criteria

  • 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 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
  • Vasectomized partner

Exclusion Criteria

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 circ
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06019559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search