Type 2 DiabetesPhase 1NCT07223333
A Study of PATAS Using Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Diabetic Subjects
A Phase 1 study testing PATAS Trifluoroacetate in people with Type 2 Diabetes, run by AdipoPharma LLC at 3 sites in United States.
Trial summary
This is 2-part study. The primary objective of Part 1 is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- PATAS Trifluoroacetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2026to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1: Single Ascending Dose Inclusion criteria
- Healthy male and female subjects, 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Form (ICF);
- Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
- Body mass index (BMI) within the range of 20.0 to 35.0 kg/m2, inclusive, at Screening;
- In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead electrocardiogram (ECG) at Screening and at Check-In (Day -1);
- Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at Check-In (Day -1) (prior to the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug;
- Negative test result for severe acute respiratory syndrome coronavirus 2 at Check-In (Day -1); and
- Willing to comply with all study procedures and requirements throughout the duration of the study.
Who cannot join
- <!-- -->
- Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary.
- Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], total bilirubin) outside the following upper limits of normal (ULNs) at Screening or at Check-In (Day -1): a. For ALT and AST, measurements > ULN; b. For ALP, measurements >ULN; or c. For total bilirubin, measurements > ULN.
- Estimated glomerular filtration rate </= 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening or at Check-In (Day -1);
- Thyroid-stimulating hormone (TSH) outside of reference range (e.g., TSH <1 × lower limit of normal [LLN] or TSH >1 × ULN) at Screening; Note: Abnormal TSH results will reflex to a free thyroxine (T4) test.
- History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease;
Show all 36Show fewer
- Personal or family history of long QT syndrome;
- Clinically significant history of any disease or disorder (i.e., gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic) deemed to be exclusionary, as judged by the Investigator;
- Abnormal pulse rate or blood pressure (BP) measurements at Screening, defined as: a. Pulse rate <40 bpm or >100 bpm; b. Systolic BP < 90 mmHg or >140 mmHg; or c. Diastolic BP < 50 mmHg or > 90 mmHg.
- Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval > 450 ms for males and >470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion;
- Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening;
- Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives prior to first study drug administration, whichever is greater, or participation in >3 clinical studies within 12 months; 22. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol);
- Part 2: Multiple Ascending Dose Inclusion Criteria
- Male and female subjects, 18 to 65 years of age, inclusive, at the time of signing the ICF;
- Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
- A diagnosis of T2D >6 months before Screening
- Subjects should be on a stable dose of
- an oral monotherapy (permitted monotherapies include metformin and dipeptidyl peptidase 4 inhibitors) for at least 90 days before Screening
- or a dual therapy (including metformin and dipeptidyl peptidase 4 inhibitors) for at least 6 months before Screening
- or managing the condition through diet and exercise for at least 90 days before Screening;
- Glycated hemoglobin 7 % and <10.5% at Screening;
- BMI within the range of 25.0 to 40.0 kg/m2, inclusive, at Screening;
- In generally good health, as judged by the Investigator, based upon medical/surgical history and the results of physical examination, vital signs, clinical laboratory assessments, and 12-lead ECG at Screening and at the pre-dose Check-In (Day -1);
- Female subjects must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test at the pre-dose Check-In (Day -1) (priorto the first dose of study drug) and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 90 days after the last dose of study drug;
- Female subjects of childbearing potential (i.e., ovulating, premenopausal, and not permanently surgically sterile) with male partners and all male subjects with female partners of childbearing potential will be included if they are either sexually inactive (complete abstinence from heterosexual activity if in line with the subject's preferred and usual lifestyle) and agree to continue complete abstinence for 90 days after the last administration of study drug, or, if sexually active, agree to use an effective contraceptive regimen during their participation in the study and for 90 days after the last administration of study drug. Effective contraceptive methods are defined as those with 90% or greater efficacy and include the following:
- For male subjects enrolled in the study: Condoms with spermicide; or Surgical sterilization (vasectomy) of the subject at least 6 months before Screening.
- For female subjects enrolled in the study: Intrauterine device for at least 90 days before Screening; Hormonal contraception (combination oral contraceptives, progestin-only oral contraceptives that inhibit ovulation, hormonal implants, progestin only injections, rings, or patches) for at least 90 days before Screening; or Bilateral tubal ligation for at least 90 days before Screening.
- Note: Sexual abstinence is considered an effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Abstinence is only acceptable if in line with the subject's preferred and usual lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea methods are not acceptable methods of contraception.
- Female subjects of nonchildbearing potential will be included if they meet the following definition of nonchildbearing potential: are either surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 90 days before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 year, with FSH in the postmenopausal range at Screening, based on the central laboratory's ranges; and
- Willing to comply with all study procedures and requirements throughout the duration of the study.
- Part 2 Multiple Ascending Dose Inclusion Criteria 1. Poorly controlled diabetes which will interfere with participation in the trial in the opinion of the Investigator, e.g., brittle diabetes, extreme fluctuation of glucoses; 2. History of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to Screening; 3. History of level 3 hypoglycemia in the 6 months prior to Screening or a history of hypoglycemia unawareness; 4. History or current evidence of type 1 diabetes or any other form of diabetes (e.g., latent autoimmune diabetes in adults, maturity onset diabetes of the young, or secondary diabetes); 5. History of active or uncontrolled diabetic complications (i.e., neuropathy, retinopathy, nephropathy, gastroparesis); Note: Diabetic complications that are, in the opinion of the Investigator, stable in condition are permitted. 6. Clinically significant history of asthma, eczema, or any other allergic condition or previous severe hypersensitivity; Note: Non-active hay fever is not exclusionary. 7. Has an active or untreated malignancy or has been in remission from malignancy for 5 years except well-treated basal cell skin cancer or cervical cancer in situ; 8. Liver function tests (ALT, AST, ALP, total bilirubin) outside the following ULNs at Screening or at Check-In (Day -1):
- For ALT and AST, measurements 3× ULN;
- For ALP, measurements >2 × ULN; or
- For total bilirubin, measurements >1.5 × ULN. 9. TSH <1 × LLN or TSH >1.5 × ULN at Screening; if a subject is on levothyroxine therapy, the subject should be on a stable dose for at least 6 weeks prior to Screening. 10. Estimated glomerular filtration rate 60 mL/min/1.73 m2 based on the CKD-EPI equation at Screening or at the pre-dose Check-In (Day -1); 11. History of unexplained syncope, cardiac arrest, unexplained cardiac arrythmias or torsades de pointes, or structural heart disease; 12. Personal or family history of long QT syndrome; 13. Clinically significant history of any disease or disorder (i.e., gastrointestinal, cardiovascular, respiratory, renal, hepatic, dermatological, or psychiatric) deemed to be exclusionary, as judged by the Investigator; 14. Recurrent or chronic pancreatitis 15. Abnormal pulse rate or BP measurements at Screening, defined as:
- Pulse rate <40 bpm or >100 bpm; b. Systolic BP <90 mmHg or >160 mmHg; or c. Diastolic BP <50 mmHg or >100 mmHg. 16. Clinically significant ECG abnormalities at Screening or at Check-In (Day -1), defined as prolongation of the average QTcF interval >450 ms for males and >470 ms for females, or other clinically significant ECG abnormalities per Investigator discretion; 17. Any other clinically significant laboratory abnormality deemed to be exclusionary, as judged by the Investigator; 18. Use of insulin, sulfonylureas, peroxisome proliferator activated receptor gamma agonists, pramlintide, sodium-glucose cotransporter 2 (SGLT2) inhibitors glucagon-like peptide-1 receptor agonists within 90 days prior to Screening; 19. Initiation of any newly prescribed or over-the-counter drugs (including vitamins, hormone replacement therapy, supplements, and natural and herbal remedies [e.g., St. John's wort]) within 90 days prior to Screening and throughout the duration of the study; Note: Paracetamol (up to 3 g per day) and contraceptives are permitted. Subjects taking prescription medications and over-the-counter medications for the treatment of concurrent medical conditions (i.e., antihypertensive agents, aspirin, lipid-lowering agents) are permitted if subjects have been on a stable dose for 30 days prior to Screening.
- 20. Use of systemic steroids for 7 days or any immunosuppressants in the 90 days prior to the pre-dose Check-In (Day -1); however, use of topical, ocular or inhaled steroids is permitted; 21. Positive urine drug screen (drugs of abuse) or urine cotinine test at Screening and/or the pre-dose Check-In (Day -1) or a history of drug/chemical abuse within 1 year prior to Screening; 22. Use of tobacco- or nicotine-containing products within 90 days prior to Screening or an unwillingness to abstain from the use of tobacco- or nicotine-containing products during the study; 23. Have typical weekly alcohol consumption of 14 alcoholic drinks. One drink is defined as 1 glass (approximately 10 to 12 oz) or 1 can (12 oz) of beer, 1 glass (approximately 4 to 5 oz) of wine, or 1 glass of distilled spirits (hard liquor) containing 1 oz of liquor; 24. Unwilling or unable to refrain from participating in contact sports or unaccustomed strenuous exercise for at least 72 hours prior to Screening, 72 hours prior to the first admission to the clinical site (e.g., the pre-dose Check-In [Day - 1]), and 72 hours prior to the visits to the clinical site on Day 8, Day 15, and Day 22 and the Follow-Up Visits on Day 28 and Day 35; 25. Unwilling to refrain from consuming liquids or foods containing caffeine or other xanthines from 48 hours prior to each admission to the clinical site (e.g., the predose Check-In [Day -1], Day 8, Day 15, and Day 22). Subjects should also refrain from consuming liquids or foods containing caffeine or other xanthines for 48 hours prior to the Follow-Up Visits on Day 28 and Day 35; 26. Subjects with extensive abdominal scarring, lipodystrophy, abdominal tattoos, or other such issues with the abdomen that would restrict the ability to perform multiple injections to the abdomen, per Investigator discretion; Note: Subjects are discouraged from getting abdominal tattoos during the study. 27. Lost or donated 450 mL of blood or blood products within 90 days prior to Screening, received a transfusion within 90 days prior to Screening, or plan to donate during the course of the study; 28. Positive for hepatitis B surface antigen, HIV antibody, or hepatitis C virus antibody at Screening; 29. Receipt of any investigational product within 30 days prior to first study drug administration (90 days for investigational biologic agents) or 5 half-lives, whichever is greater, or participation in >3 clinical studies within 12 months; 30. Known or suspected hypersensitivity to PATAS or any components of the formulation used (sodium hydroxide or mannitol); or 31. Employee of the Sponsor, the CRO, or the clinical site (e.g., permanent employee, temporary contract worker, or designee responsible for the conduct of the study) or family members (e.g., spouse, parent, sibling, or child) of the Sponsor, CRO, or other clinical site employee
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Arizona Clinical Trials
Chandler, Arizona, 85225
Samantha Zuniga, 480-470-4000, szuniga@azclinicaltrials.com
Anita Kohli, M.D.
- Recruiting
Clinical Pharmacology of Miami
Miami, Florida, 33072
Deiner Alexis Garcia, DGarcia@ergclinical.com
Angel Lamas, M.D.
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
(Jackie) Loria Boucher, 386-304-7070, Jackieb@progressivemedicalresearch.com
Richard Mohammed, M.D.
About this study
Official title: A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, 2-Part Study of Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Subjects With Type 2 Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PATAS
This is 2-part study. The primary objective of Part 1 is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. Secondary objectives of Part 2 include evaluation of the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers and characterization of of adverse event (AE) profiles of the various dose levels of PATAS.
- Conditions
- Type 2 Diabetes
- Being tested
- PATAS Trifluoroacetate, Placebo
- Keywords
- Type 2 diabetes, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATAS TrifluoroacetateDrug
A drug targeting the interaction between the ALMS1 protein and alpha-PKC
PlaceboDrug
Excipient only formulation, without active compound
| Study group | Role | What they receive |
|---|---|---|
| Diabetic subjects, Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Diabetic Subjects, Active | Experimental | Not described Receives: Drug: PATAS Trifluoroacetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1B: Safety
Incidence and severity (using CTCAE version 5.0.) of treatment-emergent AEs and SAEs
Measured: 29 days
OGTT
Oral glucose tolerance test
Measured: Baseline, Day 28
Cmax
Maximum observed plasma concentration
Measured: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
Tmax
Time to Cmax
Measured: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
AUClast
Area under the concentration-time curve (AUC) from time 0 to the last measurable plasma concentration
Measured: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
AUCinf
AUC extrapolated to infinity (AUCinf);
Measured: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
T1/2
Apparent plasma terminal elimination half-life
Measured: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
CL/F
Apparent total plasma clearance after SC injection
Measured: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance
Measured: Baseline, Day 28
TyG
Changes in triglyceride-glucose index
Measured: Baseline, Day 28
Adipo-IR
Changes in Adipose Tissue Insulin Resistance Index
Measured: Baseline, Day 28
Changes in glucose and insulin levels
Changes in glucose and insulin levels
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start27 Jan 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdipoPharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Marion, Ph.D., Study chair, AdipoPharma LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223333
- Sponsor's protocol ID
- PATAS-CL-001
- Status last verified
- Sep 2026
- First submitted
- 28 Oct 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This data is confidential.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, 2-Part Study of Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Subjects With Type 2 Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PATAS
- ClinicalTrials.gov ID
- NCT07223333
- Acronym / sponsor ID
- PATAS-CL-001
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, insulin resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- AdipoPharma LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 31 Oct 2025 (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 2-part study. The primary objective of Part 1 is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. Secondary objectives of Part 2 include evaluation of the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers and characterization of of adverse event (AE) profiles of the various dose levels of PATAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic subjects, Placebo | Placebo comparator | Drug: Placebo |
| Diabetic Subjects, Active | Experimental | Drug: PATAS Trifluoroacetate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Part 1: Single Ascending Dose Inclusion criteria
Key exclusion criteria (36 listed)
- <!-- -->
- Part 2: Multiple Ascending Dose Inclusion Criteria
- Male and female subjects, 18 to 65 years of age, inclusive, at the time of signing the ICF;
- Willing and able to give written informed consent for participation in the study prior to the initiation of any Screening or study-specific procedures;
- A diagnosis of T2D >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 |
|---|---|---|
| PATAS TrifluoroacetateA drug targeting the interaction between the ALMS1 protein and alpha-PKC | Drug | Diabetic Subjects, Active |
| PlaceboExcipient only formulation, without active compound | Drug | Diabetic subjects, Placebo |
Primary outcome
Phase 1B: Safety
Time frame: 29 days
Incidence and severity (using CTCAE version 5.0.) of treatment-emergent AEs and SAEs
OGTT
Time frame: Baseline, Day 28
Oral glucose tolerance test
Cmax
Time frame: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
Maximum observed plasma concentration
Tmax
Time frame: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
Time to Cmax
AUClast
Time frame: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
Area under the concentration-time curve (AUC) from time 0 to the last measurable plasma concentration
AUCinf
Time frame: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
AUC extrapolated to infinity (AUCinf);
T1/2
Time frame: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
Apparent plasma terminal elimination half-life
CL/F
Time frame: Pre-dose, Day 1, Day 2, Day 8, Day 15, Day 22, Day 23
Apparent total plasma clearance after SC injection
HOMA-IR
Time frame: Baseline, Day 28
Homeostatic Model Assessment of Insulin Resistance
TyG
Time frame: Baseline, Day 28
Changes in triglyceride-glucose index
Adipo-IR
Time frame: Baseline, Day 28
Changes in Adipose Tissue Insulin Resistance Index
Changes in glucose and insulin levels
Time frame: Baseline, Day 28
Changes in glucose and insulin levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. This data is confidential.
Related trials for Type 2 Diabetes
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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.
Vincent Marion, Ph.D. study chair
AdipoPharma LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PATAS Trifluoroacetate in people with Type 2 Diabetes, run by AdipoPharma LLC at 3 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 8 inclusion and 36 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek Hiwot, M.D. (44 7391 537 158, tarek.hiwot@adipopharma.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1B: Safety (time frame: 29 days). The study lists 12 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 29 Sep 2026.