A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833
NCT06019559 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2025-02-26
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
Interventions
- DRUG
-
K-757 120 mg BID and K-833 100 mg BID
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.
- DRUG
-
K-757 120 mg BID and matching placebo to K-833
K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22. Both administered orally.
- DRUG
-
Matching placebo to K-757 and matching placebo to K-833
Both administered orally.
Sponsors & Collaborators
-
Kallyope Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-15
- Primary Completion
- 2024-02-07
- Completion
- 2024-02-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity
NCT03015207 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
NCT07081958 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety Study to Evaluate BMS-830216 in Healthy Subjects
NCT00878020 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects
NCT02300844 ·Status: COMPLETED ·Phase: PHASE1
-
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
NCT03308721 ·Status: COMPLETED ·Phase: PHASE1
-
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
NCT03661879 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
NCT00747929 ·Status: COMPLETED ·Phase: PHASE2
-
GV101 in Healthy Obese Participants
NCT06979505 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I Study to Investigate the ADME of KD101
NCT02819934 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
NCT00909766 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
NCT02870231 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
NCT02958085 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Patients Being Treated With Anti-obesity Medication
NCT06790160 ·Status: RECRUITING
-
Phase II Study of THDBH120 Injection in Overweight or Obese Subjects
NCT07036601 ·Status: RECRUITING ·Phase: PHASE2
-
Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects
NCT02235961 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
NCT01515592 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability of Liraglutide in Healthy Male Volunteers
NCT01507272 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus
NCT07055516 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
NCT02243202 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
NCT01180465 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects
NCT02568319 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
NCT00665665 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants
NCT06139055 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
NCT06064006 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity
NCT00231608 ·Status: COMPLETED ·Phase: PHASE2