ObesityPhase 2NCT06019559
A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833
A Phase 2 study testing K-757 120 mg BID and K-833 100 mg BID in people with Obesity, run by TriGemX Bio, Inc. at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- K-757 120 mg BID and K-833 100 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 22 sitesUnited States
- Study dates
- 15 Sep 2023to 19 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
- Vasectomized partner
Who cannot join
- 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:
Show all 57Show fewer
- 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.
- 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.
- Has any history of pancreatitis (acute or chronic), gastroparesis, ischemic colitis, inflammatory bowel disease (IBD), or celiac disease.
- Has any personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- 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.
- 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.
- 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.
- Has any surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
- Has a history of human immunodeficiency virus (HIV) infection.
- 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.
- 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.
- 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.
- Has serum amylase or lipase >1.2X the ULN at the Screening visit.
- 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).
- Has a corrected QT interval to Fridericia's formula (QTcF) >450 milliseconds (msec) for males and >470 msec for females at screening.
- 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.
- Has known history or suspected abuse of alcohol or recreational drugs at Screening.
- 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.
- Has a positive drug screen at Screening.
- Has known or suspected hypersensitivity to trial product(s) or related products.
- 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.
- Has previous participation in this trial. Participation is defined as signed informed consent.
- Has participated in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.
- Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit.
- 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.
- Is currently in violation of study requirements for prohibited and permissible concomitant medications or is anticipated to violate these requirements during study participation.
- Has any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.
- Is unable or unwilling to follow the study nutritional and physical activity counseling and to refrain from alternative lifestyle modification strategies throughout study participation.
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Washington Center for Weight Management and Research, Inc.
Arlington, Virginia, 22206
Headlands Research - Brownsville
Brownsville, Texas, 78526
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Quest Research Institute
Farmington Hills, Michigan, 48334
Medication Management, LLC (PharmQuest)
Greensboro, North Carolina, 27408
MedStar Health Research Institute
Hyattsville, Maryland, 20782
L-MARC Research Center
Louisville, Kentucky, 40213
Health Research of Hampton Roads, Inc
Newport News, Virginia, 23606
AMR Norman
Norman, Oklahoma, 73069
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180
Summit Headlands LLC
Portland, Oregon, 97210
ActivMed Practices and Research, LLC
Portsmouth, New Hampshire, 01844
Rochester Clinical Research
Rochester, New York, 14609
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Family Practice Center of Wadsworth, Inc dba New Venture Medical Research
Wadsworth, Ohio, 44281
Reading Hospital Clinical Trials Office
West Reading, Pennsylvania, 19611
Wilmington Health (Accellacare of Wilmington)
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind 13-Week Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 in Participants Who Are Obese
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
- Being tested
- K-757 120 mg BID and K-833 100 mg BID, K-757 120 mg BID and matching placebo to K-833, Matching placebo to K-757 and matching placebo to K-833
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-757 120 mg BID and K-833 100 mg BIDDrug
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-757 120 mg BID and matching placebo to K-833Drug
K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22.
Both administered orally.
Matching placebo to K-757 and matching placebo to K-833Drug
Both administered orally.
| Study group | Role | What they receive |
|---|---|---|
| K-757+K-833 | Experimental | Not described Receives: Drug: K-757 120 mg BID and K-833 100 mg BID |
| K-757 alone | Experimental | Not described Receives: Drug: K-757 120 mg BID and matching placebo to K-833 |
| Placebo to K-757 and K-833 | Experimental | Not described Receives: Drug: Matching placebo to K-757 and matching placebo to K-833 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment
Measured: 13 weeks
Secondary outcomes (4)
The Proportion of Participants Achieving ≥5% Weight Loss After 13 Weeks of Treatment
Measured: 13 weeks
Absolute Change From Baseline in Body Weight (kg) After 13 Weeks of Treatment
Measured: 13 weeks
Proportion of Participants Who Experienced 1 or More Treatment-emergent AEs
This outcome is descriptive and no formal statistical analysis was performed.
Measured: 15 weeks
Proportion of Participants Who Discontinued Study Medication Due to an AE
This outcome is descriptive and no formal statistical analysis was performed.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start15 Sep 2023
- Primary completion7 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriGemX Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019559
- Sponsor's protocol ID
- K-757 P006
- Status last verified
- Feb 2025
- First submitted
- 25 Aug 2023
- Last updated
- 26 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind 13-Week Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 in Participants Who Are Obese
- ClinicalTrials.gov ID
- NCT06019559
- Acronym / sponsor ID
- K-757 P006
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- TriGemX Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (57 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-757 120 mg BID and K-833 100 mg BIDK-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+K-833 |
| K-757 120 mg BID and matching placebo to K-833K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22. Both administered orally. | Drug | K-757 alone |
| Matching placebo to K-757 and matching placebo to K-833Both administered orally. | Drug | Placebo to K-757 and K-833 |
Primary outcome
Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment
Time frame: 13 weeks
4 secondary outcomes
The Proportion of Participants Achieving ≥5% Weight Loss After 13 Weeks of Treatment
Time frame: 13 weeks
Absolute Change From Baseline in Body Weight (kg) After 13 Weeks of Treatment
Time frame: 13 weeks
Proportion of Participants Who Experienced 1 or More Treatment-emergent AEs
Time frame: 15 weeks
Proportion of Participants Who Discontinued Study Medication Due to an AE
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-757 120 mg BID and K-833 100 mg BID in people with Obesity, run by TriGemX Bio, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.