ObesityPhase 1NCT05900531
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers
A Phase 1 study testing K-757, K-757 and open-label sitagliptin and K-757 and K-833 in people with Obesity, run by TriGemX Bio, Inc. at 1 site in United States.
Trial summary
This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 alone, in combination with sitagliptin, or in combination with K-833. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- K-757, K-757 and open-label sitagliptin and K-757 and K-833
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 31 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the trial procedures and agree to participate by providing written informed consent.
- 2. Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements.
- 3. Be healthy between 18 to 60 years of age, inclusive, at the Screening Visit.
- 4. Have a Body Mass Index (BMI) ≥27.0 and <35.0 (kg/m2) at the Screening Visit.
- 5. Be weight stable (<5% variation) over the last 3 months.
- 6. Be a nonsmoker who has not used tobacco or nicotine-containing products (e.g. nicotine patch, e-cigarettes, vapes) for at least 3 months before administration of the initial dose of trial drug and agrees to abstain from smoking tobacco or the use of nicotine-containing products while on study.
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- 7. Be judged to be in good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug.
- 8. Meet the following requirements:
- Is a male who agrees to all of the following:
- To use an appropriate method of contraception, including a condom with or without 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 >30 mIU/mL).
- Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history.
Who cannot join
- Has participated in another interventional investigational study within 30 days of the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study. If the subject received an investigational medication in the prior study, at least 5 half-lives (or longer if required by local regulations) must have passed between the last dose of the investigational product and the Screening Visit.
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
- 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 a known hypersensitivity or contraindication to any component of K-757 (all Panels), sitagliptin (Panel C only), or K-833 (Panels D and E only), related compounds or their excipients.
- Has a positive alcohol or drug screen at Screening or admission.
- Has a positive pregnancy test.
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- Is a lactating/nursing female.
- Has a positive test result for hepatitis B surface antigen (Ag), hepatitis C virus antibody, or human immunodeficiency (HIV) antibody, at the Screening Visit. Note: Subjects 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.
- Does not meet study site COVID-19 admission/study participation restrictions.
- Has a fever (>38°C)*.
- Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit*.
- Is unable to refrain from the use of prohibited prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication through completion of study participation. Allowable concomitant medications are limited to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), ≤2 permissible anti-hypertensive agents, and post-menopausal hormone replacement therapy (HRT). Statin doses must have been stable with reported compliance of at least 80% for ≥3 months prior to the Screening Visit. Anti-hypertensive and HRT doses/regimens must have been stable for ≥1 month prior to the Screening Visit.
- Has been on any GLP-1 receptor agonist, any dipeptidyl peptidase IV (DPP-4) inhibitor, or any approved or investigational medications known to cause weight loss in the prior 3 months.
- 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) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening.
- Is unwilling or unable to refrain from consuming alcohol from 7 days prior to the first dose of study medication through the completion of study participation.
- Is unable or unwilling to refrain from consumption of Seville oranges, grapefruit, grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids from 2 weeks prior to administration of the first dose of study drug, throughout the study, and until the Follow-up Visit.
- Is unwilling to refrain from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) or charbroiled meats beginning approximately 48 hours prior to admission to the clinic, if possible (if subject has consumed any of these items prior to admission, the subject may be included in the study and the food and amount should be recorded in the source documents). Subjects will not consume any of the above foods while in the clinical research unit and until the poststudy visit.
- Has a substance abuse disorder.
- Had a previous major psychotic disorder.
- Has a corrected QT interval to Fridericia's formula (QTcF) >450 milliseconds (msec) for males and >470 msec for females at screening or on Day 1 predose.
- Has a mean value for triplicate semi-recumbent systolic blood pressure >150 mmHg and/or diastolic blood pressure (BP) >90 mmHg measured after at least 10 minutes at rest at the Screening Visit.
- Has a screening estimated glomerular filtration rate (eGFR by Modification of Diet in Renal Disease [MDRD]) <60 mL/min/1.73 m2.
- Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of >1.0X upper limit of normal (ULN) or total bilirubin >1.2X ULN (isolated bilirubin >1.2X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range) at the Screening Visit and Day -1. (Note: Subjects who do not meet this criterion during screening or check-in [Day -1] may not be rescreened/retested).
- Has serum amylase or lipase >1.2X the ULN at the Screening Visit.
- Has a recent history (within past 3 years) or current diagnosis of any of the following GI (gastro-intestinal) related diseases: intestinal obstruction, GI perforation, GI motility disorders, 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), celiac disease, irritable bowel syndrome (IBS), or colitis.
- Has any past surgical history of gastric banding or bariatric surgery or bowel resection.
- Has a history of clinically significant endocrine disease including T2DM, a screening HbA1c ≥6.5%, or a history of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurologic disorder, neoplastic, or genitourinary abnormalities or diseases.
- Has a history of unexplained arthralgias (Panel C only).
- Has a history of bullous pemphigoid (Panel C only).
- Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- note- Subject may be included if they are able to return to the site within 7 days of initial screening and the exclusion criterion is no longer met.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 28-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers
This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 alone, in combination with sitagliptin, or in combination with K-833.
- Conditions
- Obesity
- Being tested
- K-757, K-757 and open-label sitagliptin, Matching placebo to K-757, Matching placebo to K-757 and matching placebo to K-833, K-757 and K-833
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-757Drug
administered orally
K-757 and open-label sitagliptinDrug
both administered orally
Matching placebo to K-757Drug
administered orally
Matching placebo to K-757 and matching placebo to K-833Drug
both administered orally
K-757 and K-833Drug
both administered orally
Matching placebo to K-757, open-label sitagliptinDrug
both administered orally
| Study group | Role | What they receive |
|---|---|---|
| K-757 (Panel A) | Experimental | Not described Receives: Drug: K-757 |
| K-757 (Panel B) | Experimental | Not described Receives: Drug: K-757 |
| K-757 + sitaglipitin (Panel C) | Experimental | Not described Receives: Drug: K-757 and open-label sitagliptin |
| K-757 and K-833 (Panel D) | Experimental | Not described Receives: Drug: K-757 and K-833 |
| K-757 and K-833 (Panel E) | Experimental | Not described Receives: Drug: K-757 and K-833 |
| Panel A | Placebo comparator | Not described Receives: Drug: Matching placebo to K-757 |
| Panel B | Placebo comparator | Not described Receives: Drug: Matching placebo to K-757 |
| Panel C (+ sitagliptin) | Placebo comparator | Not described Receives: Drug: Matching placebo to K-757, open-label sitagliptin |
| Panel D | Placebo comparator | Not described Receives: Drug: Matching placebo to K-757 and matching placebo to K-833 |
| Panel E | Placebo comparator | 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.
Proportion of participants who experienced 1 or more treatment-emergent AEs
after treatment with K-757 administered alone, when co-administered with sitagliptin, and when co-administered with K-833
Measured: Up to Day 42 +/- 2 days
Proportion of participants who discontinued study medication due to an AE
after treatment with K-757 administered alone, when co-administered with sitagliptin, and when co-administered with K-833
Measured: Up to Day 42 +/- 2 days
Secondary outcomes (24)
Area under the concentration-time curve [AUC] of plasma K-757
following multiple doses of K-757
Measured: Days 1 and 28
Maximum concentration [Cmax] of plasma K-757
following multiple doses of K-757
Measured: Days 1 and 28
Time of maximum concentration [Tmax] of plasma K-757
following multiple doses of K-757
Measured: Days 1 and 28
Clearance [Cl] of plasma K-757
following multiple doses of K-757
Measured: Days 1 and 28
Volume of distribution at steady-state [Vdss] of plasma K-757
following multiple doses of K-757
Measured: Days 1 and 28
Half-life [t1/2] of plasma K-757
following multiple doses of K-757
Measured: Days 1 and 28
AUC of plasma K-757
following multiple doses of K-757 when co-administered with sitagliptin
Measured: Days 1 and 28
Cmax of plasma K-757
following multiple doses of K-757 when co-administered with sitagliptin
Measured: Days 1 and 28
Tmax of plasma K-757
following multiple doses of K-757 when co-administered with sitagliptin
Measured: Days 1 and 28
Cl of plasma K-757
following multiple doses of K-757 when co-administered with sitagliptin
Measured: Days 1 and 28
Vdss of plasma K-757
following multiple doses of K-757 when co-administered with sitagliptin
Measured: Days 1 and 28
t1/2 of plasma K-757
following multiple doses of K-757 when co-administered with sitagliptin
Measured: Days 1 and 28
AUC of plasma K-757
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Cmax of plasma K-757
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Tmax of plasma K-757
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Cl of plasma K-757
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Vdss of plasma K-757
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
t1/2 of plasma K-757
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
AUC of plasma K-833
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Cmax of plasma K-833
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Tmax of plasma K-833
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Cl of plasma K-833
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Vdss of plasma K-833
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
t1/2 of plasma K-833
following multiple doses of K-757 when co-administered with K-833
Measured: Days 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start21 Sep 2022
- Primary completion3 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 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
- NCT05900531
- Sponsor's protocol ID
- K-757 P004
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers
- ClinicalTrials.gov ID
- NCT05900531
- Acronym / sponsor ID
- K-757 P004
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TriGemX Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
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 multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 alone, in combination with sitagliptin, or in combination with K-833.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| K-757 (Panel A) | Experimental | Drug: K-757 |
| K-757 (Panel B) | Experimental | Drug: K-757 |
| K-757 + sitaglipitin (Panel C) | Experimental | Drug: K-757 and open-label sitagliptin |
| K-757 and K-833 (Panel D) | Experimental | Drug: K-757 and K-833 |
| K-757 and K-833 (Panel E) | Experimental | Drug: K-757 and K-833 |
| Panel A | Placebo comparator | Drug: Matching placebo to K-757 |
| Panel B | Placebo comparator | Drug: Matching placebo to K-757 |
| Panel C (+ sitagliptin) | Placebo comparator | Drug: Matching placebo to K-757, open-label sitagliptin |
| Panel D | Placebo comparator | Drug: Matching placebo to K-757 and matching placebo to K-833 |
| Panel E | Placebo comparator | Drug: Matching placebo to K-757 and matching placebo to K-833 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Understand the trial procedures and agree to participate by providing written informed consent.
- 2. Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements.
- 3. Be healthy between 18 to 60 years of age, inclusive, at the Screening Visit.
- 4. Have a Body Mass Index (BMI) ≥27.0 and <35.0 (kg/m2) at the Screening Visit.
- 5. Be weight stable (<5% variation) over the last 3 months.
Key exclusion criteria (32 listed)
- Has participated in another interventional investigational study within 30 days of the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study. If the subject received an investigational medication in the prior study, at least 5 half-lives (or longer if required by local regulations) must have passed between the last dose of the investigational product and the Screening Visit.
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
- 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 a known hypersensitivity or contraindication to any component of K-757 (all Panels), sitagliptin (Panel C only), or K-833 (Panels D and E only), related compounds or their excipients.
- Has a positive alcohol or drug screen at Screening or admission.
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-757administered orally | Drug | K-757 (Panel A), K-757 (Panel B) |
| K-757 and open-label sitagliptinboth administered orally | Drug | K-757 + sitaglipitin (Panel C) |
| Matching placebo to K-757administered orally | Drug | Panel A, Panel B |
| Matching placebo to K-757 and matching placebo to K-833both administered orally | Drug | Panel D, Panel E |
| K-757 and K-833both administered orally | Drug | K-757 and K-833 (Panel D), K-757 and K-833 (Panel E) |
| Matching placebo to K-757, open-label sitagliptinboth administered orally | Drug | Panel C (+ sitagliptin) |
Primary outcome
Proportion of participants who experienced 1 or more treatment-emergent AEs
Time frame: Up to Day 42 +/- 2 days
after treatment with K-757 administered alone, when co-administered with sitagliptin, and when co-administered with K-833
Proportion of participants who discontinued study medication due to an AE
Time frame: Up to Day 42 +/- 2 days
after treatment with K-757 administered alone, when co-administered with sitagliptin, and when co-administered with K-833
24 secondary outcomes
Area under the concentration-time curve [AUC] of plasma K-757
Time frame: Days 1 and 28
Maximum concentration [Cmax] of plasma K-757
Time frame: Days 1 and 28
Time of maximum concentration [Tmax] of plasma K-757
Time frame: Days 1 and 28
Clearance [Cl] of plasma K-757
Time frame: Days 1 and 28
Volume of distribution at steady-state [Vdss] of plasma K-757
Time frame: Days 1 and 28
Half-life [t1/2] of plasma K-757
Time frame: Days 1 and 28
AUC of plasma K-757
Time frame: Days 1 and 28
Cmax of plasma K-757
Time frame: Days 1 and 28
Tmax of plasma K-757
Time frame: Days 1 and 28
Cl of plasma K-757
Time frame: Days 1 and 28
Vdss of plasma K-757
Time frame: Days 1 and 28
t1/2 of plasma K-757
Time frame: Days 1 and 28
AUC of plasma K-757
Time frame: Days 14 and 28
Cmax of plasma K-757
Time frame: Days 14 and 28
Tmax of plasma K-757
Time frame: Days 14 and 28
Cl of plasma K-757
Time frame: Days 14 and 28
Vdss of plasma K-757
Time frame: Days 14 and 28
t1/2 of plasma K-757
Time frame: Days 14 and 28
AUC of plasma K-833
Time frame: Days 14 and 28
Cmax of plasma K-833
Time frame: Days 14 and 28
Tmax of plasma K-833
Time frame: Days 14 and 28
Cl of plasma K-833
Time frame: Days 14 and 28
Vdss of plasma K-833
Time frame: Days 14 and 28
t1/2 of plasma K-833
Time frame: Days 14 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing K-757, K-757 and open-label sitagliptin and K-757 and K-833 in people with Obesity, run by TriGemX Bio, Inc. at 1 site 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 16 inclusion and 32 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants who experienced 1 or more treatment-emergent AEs (time frame: Up to Day 42 +/- 2 days). The study lists 2 primary outcomes in all. 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 22 Nov 2024.