A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833
NCT ID: NCT06019559
Last Updated: 2025-02-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
155 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-15
Study Completion Date
2024-02-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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K-757+K-833
Group Type
EXPERIMENTAL
K-757 120 mg BID and K-833 100 mg BID
Intervention Type
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 alone
Group Type
EXPERIMENTAL
K-757 120 mg BID and matching placebo to K-833
Intervention Type
DRUG
K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22.
Both administered orally.
Placebo to K-757 and K-833
Group Type
EXPERIMENTAL
Matching placebo to K-757 and matching placebo to K-833
Intervention Type
DRUG
Both administered orally.
Interventions
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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.
Intervention Type
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.
Intervention Type
DRUG
Matching placebo to K-757 and matching placebo to K-833
Both administered orally.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions, including following study diet requirements.
3. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent.
4. Have a body mass index (BMI) of 30.0 to \<40.0. kg/m2, inclusive.
5. History of at least one self-reported unsuccessful dietary effort to lose body weight.
6. Be weight stable (\<5% variation) over the last 3 months (by subject report).
7. 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.
8. Meet the following requirements:
1. 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
2. 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
3. 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
2. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions, including following study diet requirements.
3. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent.
4. Have a body mass index (BMI) of 30.0 to \<40.0. kg/m2, inclusive.
5. History of at least one self-reported unsuccessful dietary effort to lose body weight.
6. Be weight stable (\<5% variation) over the last 3 months (by subject report).
7. 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.
8. Meet the following requirements:
1. 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
2. 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
3. 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:
1. Has a hemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) as measured by the central laboratory at screening.
2. 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.
3. Has a history of type 1 or type 2 diabetes mellitus.
4. Had treatment with any glucose-lowering agent(s) within 90 days before screening.
Obesity related:
5. 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.
6. 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.
7. Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist in the prior 6 months.
8. Participation in an organized weight reduction program (e.g. Weight Watchers) within 90 days of screening.
9. 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).
10. 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.
11. Obesity is induced by an endocrine disorder (e.g. Cushing's disease).
Mental health:
12. Has a history of major depressive disorder within 2 years before screening unless all of the following criteria are met:
1. the depressive disorder has always been unipolar (no history of mania or hypomania)
2. in the opinion of the investigator, depressive symptoms have been stable and well controlled for ≥ 2 years prior to screening.
3. any anti-depressant drug-treatment regimens (medications and doses) have been stable for ≥6 months prior to screening.
13. 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.
14. 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).
15. 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.
16. Use of any anti-psychotic agents for any purpose within 2 years before screening.
17. 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:
18. 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.
19. Has a recent history (within past 3 years of the screening visit) or current diagnosis of any of the following GI (gastro intestinal) related diseases: intestinal obstruction, GI perforation, adhesions, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening.
20. Has any history of pancreatitis (acute or chronic), gastroparesis, ischemic colitis, inflammatory bowel disease (IBD), or celiac disease.
21. Has any personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
22. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<60 ml/min/1.73 m2.
23. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
24. Has any history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, clinically significant conduction disorders, or any history or heart failure.
25. Has any surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
26. Has a history of human immunodeficiency virus (HIV) infection.
27. Has any active liver disease other than non-alcoholic fatty liver disease (NAFLD), or any gallbladder disease that has been active/symptomatic within 6 months of screening.
28. Has a positive test result for hepatitis B surface antigen (Ag), hepatitis C virus antibody, or HIV antibody, at the Screening Visit. Note: Participants 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.
29. Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of \>2.0X upper limit of normal (ULN) or total bilirubin \>1.5X ULN at the Screening visit. Note: An isolated bilirubin \>1.5X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range.
30. Has serum amylase or lipase \>1.2X the ULN at the Screening visit.
31. Has a triglycerides value of \>600mg/dL at the Screening visit (if value is ≥600 mg/dL and the sample was obtained in the non-fasted state, a repeat fasting determination may be obtained to assess eligibility).
32. Has a corrected QT interval to Fridericia's formula (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females at screening.
33. Has a mean value for triplicate semi-recumbent systolic blood pressure \>160 mmHg and/or diastolic blood pressure (BP) \>95 mmHg measured after at least 10 minutes at rest at the Screening Visit.
Note: If a subject's BP is exclusionary on the first triplicate assessment at the Screening visit, they may have 1 repeat triplicate BP assessment at that visit after another rest of at least 10 minutes.
If a participant's BP is exclusionary on 2 assessments at the Screening visit, the investigator can, at their discretion, adjust and/or add anti-hypertensive medications and re-assess triplicate BP up to twice prior to dosing at the Randomization visit (Visit 2). Anti-hypertensive regimens must be ≤2 agents that do not include verapamil.
If a participant's BP is exclusionary at the Screening visit and the Randomization visit (Visit 2), they must be excluded.
34. Has known history or suspected abuse of alcohol or recreational drugs at Screening.
35. 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 or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD)) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening.
36. Has a positive drug screen at Screening.
37. Has known or suspected hypersensitivity to trial product(s) or related products.
38. 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.
39. Has previous participation in this trial. Participation is defined as signed informed consent.
40. Has participated in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
41. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit.
42. Is a female who is pregnant, breast-feeding or intends to become pregnant during the planned course of the study. Note: Participants must have a negative serum pregnancy test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory prior to enrollment in the study and prior to the randomization visit.
43. Is currently in violation of study requirements for prohibited and permissible concomitant medications or is anticipated to violate these requirements during study participation.
45. Is unable or unwilling to follow the study nutritional and physical activity counseling and to refrain from alternative lifestyle modification strategies throughout study participation.
46. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
Note: Rescreening/retesting is not permitted unless specified above.
1. Has a hemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) as measured by the central laboratory at screening.
2. 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.
3. Has a history of type 1 or type 2 diabetes mellitus.
4. Had treatment with any glucose-lowering agent(s) within 90 days before screening.
Obesity related:
5. 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.
6. 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.
7. Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist in the prior 6 months.
8. Participation in an organized weight reduction program (e.g. Weight Watchers) within 90 days of screening.
9. 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).
10. 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.
11. Obesity is induced by an endocrine disorder (e.g. Cushing's disease).
Mental health:
12. Has a history of major depressive disorder within 2 years before screening unless all of the following criteria are met:
1. the depressive disorder has always been unipolar (no history of mania or hypomania)
2. in the opinion of the investigator, depressive symptoms have been stable and well controlled for ≥ 2 years prior to screening.
3. any anti-depressant drug-treatment regimens (medications and doses) have been stable for ≥6 months prior to screening.
13. 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.
14. 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).
15. 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.
16. Use of any anti-psychotic agents for any purpose within 2 years before screening.
17. 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:
18. 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.
19. Has a recent history (within past 3 years of the screening visit) or current diagnosis of any of the following GI (gastro intestinal) related diseases: intestinal obstruction, GI perforation, adhesions, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening.
20. Has any history of pancreatitis (acute or chronic), gastroparesis, ischemic colitis, inflammatory bowel disease (IBD), or celiac disease.
21. Has any personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
22. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<60 ml/min/1.73 m2.
23. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
24. Has any history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, clinically significant conduction disorders, or any history or heart failure.
25. Has any surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
26. Has a history of human immunodeficiency virus (HIV) infection.
27. Has any active liver disease other than non-alcoholic fatty liver disease (NAFLD), or any gallbladder disease that has been active/symptomatic within 6 months of screening.
28. Has a positive test result for hepatitis B surface antigen (Ag), hepatitis C virus antibody, or HIV antibody, at the Screening Visit. Note: Participants 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.
29. Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of \>2.0X upper limit of normal (ULN) or total bilirubin \>1.5X ULN at the Screening visit. Note: An isolated bilirubin \>1.5X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range.
30. Has serum amylase or lipase \>1.2X the ULN at the Screening visit.
31. Has a triglycerides value of \>600mg/dL at the Screening visit (if value is ≥600 mg/dL and the sample was obtained in the non-fasted state, a repeat fasting determination may be obtained to assess eligibility).
32. Has a corrected QT interval to Fridericia's formula (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females at screening.
33. Has a mean value for triplicate semi-recumbent systolic blood pressure \>160 mmHg and/or diastolic blood pressure (BP) \>95 mmHg measured after at least 10 minutes at rest at the Screening Visit.
Note: If a subject's BP is exclusionary on the first triplicate assessment at the Screening visit, they may have 1 repeat triplicate BP assessment at that visit after another rest of at least 10 minutes.
If a participant's BP is exclusionary on 2 assessments at the Screening visit, the investigator can, at their discretion, adjust and/or add anti-hypertensive medications and re-assess triplicate BP up to twice prior to dosing at the Randomization visit (Visit 2). Anti-hypertensive regimens must be ≤2 agents that do not include verapamil.
If a participant's BP is exclusionary at the Screening visit and the Randomization visit (Visit 2), they must be excluded.
34. Has known history or suspected abuse of alcohol or recreational drugs at Screening.
35. 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 or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD)) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening.
36. Has a positive drug screen at Screening.
37. Has known or suspected hypersensitivity to trial product(s) or related products.
38. 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.
39. Has previous participation in this trial. Participation is defined as signed informed consent.
40. Has participated in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
41. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit.
42. Is a female who is pregnant, breast-feeding or intends to become pregnant during the planned course of the study. Note: Participants must have a negative serum pregnancy test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory prior to enrollment in the study and prior to the randomization visit.
43. Is currently in violation of study requirements for prohibited and permissible concomitant medications or is anticipated to violate these requirements during study participation.
45. Is unable or unwilling to follow the study nutritional and physical activity counseling and to refrain from alternative lifestyle modification strategies throughout study participation.
46. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
Note: Rescreening/retesting is not permitted unless specified above.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Kallyope Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Artemis Institute for Clinical Research, LLC
San Diego, California, United States
Site Status
Clinical Research Atlanta
Stockbridge, Georgia, United States
Site Status
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Site Status
L-MARC Research Center
Louisville, Kentucky, United States
Site Status
MedStar Health Research Institute
Hyattsville, Maryland, United States
Site Status
Quest Research Institute
Farmington Hills, Michigan, United States
Site Status
ActivMed Practices and Research, LLC
Portsmouth, New Hampshire, United States
Site Status
Rochester Clinical Research
Rochester, New York, United States
Site Status
Medication Management, LLC (PharmQuest)
Greensboro, North Carolina, United States
Site Status
Wilmington Health (Accellacare of Wilmington)
Wilmington, North Carolina, United States
Site Status
Family Practice Center of Wadsworth, Inc dba New Venture Medical Research
Wadsworth, Ohio, United States
Site Status
AMR Norman
Norman, Oklahoma, United States
Site Status
Summit Headlands LLC
Portland, Oregon, United States
Site Status
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Site Status
Reading Hospital Clinical Trials Office
West Reading, Pennsylvania, United States
Site Status
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Site Status
Headlands Research - Brownsville
Brownsville, Texas, United States
Site Status
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, United States
Site Status
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Site Status
Washington Center for Weight Management and Research, Inc.
Arlington, Virginia, United States
Site Status
Charlottesville Medical Research
Charlottesville, Virginia, United States
Site Status
Health Research of Hampton Roads, Inc
Newport News, Virginia, United States
Site Status
Countries
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United States
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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K-757 P006
Identifier Type: -
Identifier Source: org_study_id
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Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
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COMPLETED
PHASE1
Safety and Tolerability of Liraglutide in Healthy Male Volunteers
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COMPLETED
PHASE1
Evaluate the Efficacy and Safety of NT-0796 in Participants With Obesity With or Without Type 2 Diabetes Mellitus
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ACTIVE_NOT_RECRUITING
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
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COMPLETED
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
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COMPLETED
PHASE2
Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects
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COMPLETED
PHASE2
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
NCT00665665
TERMINATED
PHASE1
A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants
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ACTIVE_NOT_RECRUITING
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
COMPLETED
PHASE2
A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity
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COMPLETED
PHASE2