ObesityPhase 1NCT06305351
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes
A Phase 1 study testing K-757 and K-833 QD and K-757 and K-833 BID in people with Obesity and Type 2 Diabetes Mellitus (T2DM), 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 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- K-757 and K-833 QD and K-757 and K-833 BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 21 Jun 2024
- 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 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.
- Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements.
- Be between 18 to 70 years of age, inclusive, at the Screening Visit.
- Has T2DM in accordance with American Diabetes Association (ADA) guidelines at the Screening Visit.
- Is on stable metformin monotherapy (total daily dose of 1,000 to 2,000 mg/day) for at least 3 months and tolerating metformin well in the opinion of the investigator. Note: Both the immediate release (IR) and extended release (XR) formulations of metformin are acceptable.
- HbA1c of ≤7.5% at Screening.
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- Have a Body Mass Index (BMI) ≥25.0 and <40.0 (kg/m2) at the Screening Visit.
- Be weight stable (<5% variation) over the last 3 months, by subject report.
- 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.
- Be judged to be in generally 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.
- Meet the following requirements:
- Is a male who agrees to all of the following:
- If partner is a non-pregnant female of child-bearing potential: To use an appropriate method of contraception, including a condom with 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 has had a vasectomy procedure must use a condom but is not required to use spermicidal cream or jelly.
- If partner is pregnant, to use a condom. Note: Contraception/condom requirements are waived if partner is NOT of child-bearing potential (i.e. is male or is a female who is post-menopausal or surgically sterile [post-hysterectomy, post-bilateral oophorectomy, and/or post-bilateral salpingectomy]).
- 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 as established for the laboratory performing the test.
- 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 activitya or
- agrees to use (or have their partner use) a birth control method that is highly effective and has low user dependency. 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 a Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
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 (eg, 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, K-833, including 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 may include 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), ≤2 permissible anti-hypertensive agents, postmenopausal hormone replacement therapy (HRT), and/or proton pump inhibitors (PPIs).
- 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 a history of type 1 diabetes mellitus (T1DM) or a history of diabetic ketoacidosis or subject assessed by the investigator as possibly having T1DM.
- Has a history of other specific types of diabetes (e.g. genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post organ transplant diabetes).
- Has been treated with insulin or any other anti-hyperglycemic agents (AHAs) other than metformin within 4 weeks of screening or within 12 weeks of screening if the AHA was a thiazolidinedione (e.g., rosiglitazone, pioglitazone).
- At Screening or Day 1 has a site fasting fingerstick glucose of >270 mg/dL. If the Day -1 fasting fingerstick glucose is >270 mg/dL, a re-test may be conducted the morning of Day1 in fasted state prior to randomization. If the result is ≤270 mg/dL, the subject may be randomized if all other entry criteria are met.
- Has evidence or history of diabetic complications or significant end organ damage, eg, proliferative retinopathy and/or macular edema, eGFR Modification of Diet in Renal Disease (MDRD) ≤60 mL/min, diabetic neuropathy.
- One or more self-reported episodes of hypoglycemia (fingerstick glucose <60 mg/dL with symptoms consistent with hypoglycemia or <50 mg/dL irrespective of symptoms) within the last 3 months.
- Is using or anticipates the need for using concomitant medications which are inhibitors of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) or any prohibited medications listed in Section 10.1 from screening until the post study visit.
- 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 any 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.
- 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.
- 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 admission.
- Has a mean value for triplicate semi-recumbent systolic blood pressure >160 millimeters of mercury (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, to qualify for the study.
- If a subject's BP is exclusionary at screening but the investigator feels that BP is likely to be below the exclusionary thresholds at admission (Day -1), this criterion can be re-assessed at admission. Adjustment of doses of anti-hypertensives already being taken at screening is permissible, but initiation of new agents is not permissible. For subjects whose BP is exclusionary at Screening and at the first triplicate assessment on Day -1, triplicate assessments can be repeated up to twice on Day -1, as needed.
- Triplicate assessments should occur after a rest of at least 10 min. Also, the first measurement of any triplicate assessment should be separated from the last measurement in a prior triplicate assessment by at least 10 minutes.
- Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of >1.5X upper limit of normal (ULN) or total bilirubin >1.5X ULN (isolated bilirubin >1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range) at Screening or admission. (Note: Subjects who do not meet this criterion at Screening or at admission 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, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurologic disorder, neoplastic, or genitourinary abnormalities or diseases.
- 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 42-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 And K-833 in Overweight/Obese Patients With Type 2 Diabetes Mellitus
This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM)
- Conditions
- Obesity, Type 2 Diabetes Mellitus (T2DM)
- Being tested
- K-757 and K-833 QD, K-757 and K-833 BID, Matching placebo to K-757 and K-833 QD, Matching placebo to K-757 and K-833 BID
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-757 and K-833 QDDrug
Both administered orally once daily
K-757 and K-833 BIDDrug
Both administered orally twice daily
Matching placebo to K-757 and K-833 QDDrug
Both administered orally once daily
Matching placebo to K-757 and K-833 BIDDrug
Both administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| K-757 and K-833 combination | Experimental | Not described Receives: Drug: K-757 and K-833 QD; Drug: K-757 and K-833 BID |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo to K-757 and K-833 QD; Drug: Matching placebo to K-757 and K-833 BID |
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
Measured: Up to Day 43 +/- 2 days
Proportion of participants who discontinued study medication due to an AE
Measured: Up to Day 43 +/- 2 days
Secondary outcomes (12)
Area under the concentration-time curve [AUC] of plasma K-757
when co-administered with K-833
Measured: Days 1, 28, 42
AUC of plasma K-833
when co-administered with K-757
Measured: Days 1, 28, 42
Maximum concentration [Cmax] of plasma K-757
when co-administered with K-833
Measured: Days 1, 28, 42
Cmax of plasma K-833
when co-administered with K-757
Measured: Days 1, 28, 42
Time of maximum concentration [Tmax] of plasma K-757
when co-administered with K-833
Measured: Days 1, 28, 42
Tmax of plasma K-833
when co-administered with K-757
Measured: Days 1, 28, 42
Clearance [Cl] of plasma K-757
when co-administered with K-833
Measured: Days 1, 28, 42
Cl of plasma K-833
when co-administered with K-757
Measured: Days 1, 28, 42
Volume of distribution at steady-state [Vdss] of plasma K-757
when co-administered with K-833
Measured: Days 1, 28, 42
Vdss of plasma K-833
when co-administered with K-757
Measured: Days 1, 28, 42
Half-life [t1/2] of plasma K-757
when co-administered with K-833
Measured: Days 1, 28, 42
t1/2 of plasma K-833
when co-administered with K-757
Measured: Days 1, 28, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start7 Dec 2023
- Primary completion15 May 2024
- Study completion21 Jun 2024
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 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
- NCT06305351
- Sponsor's protocol ID
- K-757 P008
- Status last verified
- Oct 2024
- First submitted
- 5 Mar 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 42-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 And K-833 in Overweight/Obese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06305351
- Acronym / sponsor ID
- K-757 P008
- Conditions
- Obesity, Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TriGemX Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 12 Mar 2024 (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 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K-757 and K-833 combination | Experimental | Drug: K-757 and K-833 QD, Drug: K-757 and K-833 BID |
| Placebo | Placebo comparator | Drug: Matching placebo to K-757 and K-833 QD, Drug: Matching placebo to K-757 and K-833 BID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Understand the trial procedures and agree to participate by providing written informed consent.
- Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements.
- Be between 18 to 70 years of age, inclusive, at the Screening Visit.
- Has T2DM in accordance with American Diabetes Association (ADA) guidelines at the Screening Visit.
- Is on stable metformin monotherapy (total daily dose of 1,000 to 2,000 mg/day) for at least 3 months and tolerating metformin well in the opinion of the investigator. Note: Both the immediate release (IR) and extended release (XR) formulations of metformin are acceptable.
Key exclusion criteria (37 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 (eg, 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, K-833, including 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-757 and K-833 QDBoth administered orally once daily | Drug | K-757 and K-833 combination |
| K-757 and K-833 BIDBoth administered orally twice daily | Drug | K-757 and K-833 combination |
| Matching placebo to K-757 and K-833 QDBoth administered orally once daily | Drug | Placebo |
| Matching placebo to K-757 and K-833 BIDBoth administered orally twice daily | Drug | Placebo |
Primary outcome
Proportion of participants who experienced 1 or more treatment-emergent AEs
Time frame: Up to Day 43 +/- 2 days
Proportion of participants who discontinued study medication due to an AE
Time frame: Up to Day 43 +/- 2 days
12 secondary outcomes
Area under the concentration-time curve [AUC] of plasma K-757
Time frame: Days 1, 28, 42
AUC of plasma K-833
Time frame: Days 1, 28, 42
Maximum concentration [Cmax] of plasma K-757
Time frame: Days 1, 28, 42
Cmax of plasma K-833
Time frame: Days 1, 28, 42
Time of maximum concentration [Tmax] of plasma K-757
Time frame: Days 1, 28, 42
Tmax of plasma K-833
Time frame: Days 1, 28, 42
Clearance [Cl] of plasma K-757
Time frame: Days 1, 28, 42
Cl of plasma K-833
Time frame: Days 1, 28, 42
Volume of distribution at steady-state [Vdss] of plasma K-757
Time frame: Days 1, 28, 42
Vdss of plasma K-833
Time frame: Days 1, 28, 42
Half-life [t1/2] of plasma K-757
Time frame: Days 1, 28, 42
t1/2 of plasma K-833
Time frame: Days 1, 28, 42
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 1 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 and K-833 QD and K-757 and K-833 BID in people with Obesity and Type 2 Diabetes Mellitus (T2DM), 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 29 inclusion and 37 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 1 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 43 +/- 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 1 Nov 2024.