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ObesityPhase 1NCT04890873

ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity

A Phase 1 study testing ERX1000 in people with Obesity, run by ERX Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to assess the safety and tolerability of single and multiple oral doses of ERX1000 in obese subjects. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity
What is being tested?
ERX1000
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
17 Oct 2019to 3 Jul 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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
  • Adult females and males, of any race, between 18 and 55 years of age, inclusive, at Screening.
  • Females of non-childbearing potential, which is defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or with bilateral tubal ligation or Essure® (hysteroscopic bilateral tubal occlusion) with confirmation of occlusion of the fallopian tubes performed at least 3 months prior to Screening, or postmenopausal (defined as at least 12 months post cessation of menses without an alternative medical cause and follicle-stimulating hormone [FSH] level
  • ≥ 40 mIU/mL). Males will agree to use contraception and refrain from sperm donation.
  • Body mass index between 30.0 and 39.9 kg/m^2, inclusive, at Screening.
  • Glycosylated hemoglobin (HbA1c) level of < 6.5% at Screening (test may be repeated once for confirmation of out-of-range values).
Show all 11Show fewer
  • Vital signs at Screening and Check-in as per the following ranges and stable (measured in a supine position after a minimum of 5 minutes of rest):
  • Systolic blood pressure ≥ 90 and ≤ 140 mmHg
  • Diastolic blood pressure ≥ 50 and ≤ 90 mmHg
  • Pulse rate ≥ 50 and ≤ 100 bpm.
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).

Who cannot join

  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dose administration on Day 1.
  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  • Obesity induced by known endocrine or genetic disorders (eg, Cushing syndrome, hypothyroidism, Prader Willi syndrome).
  • Any previous surgical treatment or procedures with medical devices (such as insertion of lap band or gastric balloons) for obesity (excluding liposuction if performed > 1 year prior to Check-in).
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, which would increase the subject's risk of participation.
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair > 6 months prior to Screening will be allowed).
Show all 35Show fewer
  • History or evidence of underlying liver disease, including viral (hepatitis B and C) or alcoholic hepatitis, or confirmed diagnosis of nonalcoholic steatohepatitis (NASH); nonalcoholic fatty liver disease with qualifying liver function tests (LFTs) will be allowed.
  • Gilbert's Syndrome (congenital non-hemolytic hyperbilirubinemia) or suspicion of Gilbert's Syndrome based on total and direct bilirubin.
  • Laboratory results that exceed the following thresholds at Screening AND Check-in (laboratory tests may be repeated once for confirmation of out-of-range values) as specified:
  • alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN)
  • aspartate aminotransferase (AST) > 1.5 × ULN
  • gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin, or International Normalized Ratio (INR) > ULN
  • Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration < 13.0 g/dL [130 g/L] for males, < 11.0 g/dL [110 g/L] for females) at Screening or any other condition known to interfere with interpretation of HbA1c measurement
  • Neutrophils < 1.5 × 109/L deemed clinically significant by Investigator upon a confirmatory repeat
  • Thyroid-stimulating hormone (TSH) level above the normal range, confirmed on repeat.
  • History or presence of cardiac arrhythmia (at the discretion of the Investigator) or congenital long QT syndrome.
  • A QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec for males or > 470 msec for females on Screening ECG. At the discretion of the Investigator, ECG may be repeated twice and an average taken of the 3 readings.
  • The subject has creatinine clearance ≤ 80 mL/minute as calculated using the Cockroft-Gault equation. At the discretion of the Investigator, evaluation may be repeated once to confirm.
  • History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
  • Alcohol consumption of > 14 units per week. One unit of alcohol equals 12 oz (360 mL) of beer, 1½ oz (45 mL) of liquor, or 5 oz (150 mL) of wine.
  • Positive urine drug screen at Screening; or positive alcohol breath test result or positive urine drug screen at Check-in.
  • Positive hepatitis B surface antigen and/or hepatitis C antibody and/or positive human immunodeficiency virus 1/2 (Appendix 2).
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
  • Subjects who are actively dieting, have gained or lost > 5 pounds, or using or intend to use any prescription or nonprescription drugs for weight loss including herbal or other dietary supplements within 3 months prior to Check-in.
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in and throughout the outpatient Follow-up period.
  • Use or intend to use any prescription medications/products within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  • Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to Check-in and throughout the outpatient Follow-up period, unless deemed acceptable by the Investigator (or designee).
  • Consumption of alcohol from 72 hours prior to Check-in.
  • Use of tobacco- or nicotine-containing products (including nicotine and non-nicotine e-cigarettes, vaping, etc.) within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.
  • Receipt of blood products within 2 months prior to Check-in.
  • Donation of blood from 8 weeks prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  • Poor peripheral venous access.
  • Have previously completed or withdrawn from this study or any other study investigating ERX1000, and have previously received the investigational product.
  • Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Labcorp Clinical Research Unit Inc.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: ERX1000 - A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity

The primary objective is to assess the safety and tolerability of single and multiple oral doses of ERX1000 in obese subjects.

Conditions
Obesity
Being tested
ERX1000, Placebo
Keywords
ERX1000, Obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERX1000Drug

    ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension

  • PlaceboDrug

    Also called Magnesium hydroxide carbonate

    A suspension containing magnesium hydroxide carbonate in polysorbate

Study groups in NCT04890873
Study groupRoleWhat they receive
ERX1000ExperimentalERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension Proposed dose level for Part A: 4 mg and 8 mg Proposed dose level for Part B: 4 and 8 mg. The dose administered will not exceed the highest dose administered in Part A.
Receives: Drug: ERX1000
PlaceboPlacebo comparatorReference product: Magnesium hydroxide carbonate powder prepared in an oral suspension
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A (Single Dose Group A9): Incidence and severity of adverse events (AEs)

    Measured: Day 1 up to end of study (Day 10)

  2. Part A (Single Dose Group A9): Incidence of clinical laboratory abnormalities

    Measured: Screening (Day -28) up to end of study (Day 10)

  3. Part A (Single Dose Group A9): Incidence of 12-lead electrocardiogram (ECG) abnormalities

    Measured: Screening (Day -28 to Day -2), Days 1, 3 and 10

  4. Part A (Single Dose Group A9): Incidence of vital sign abnormalities

    Measured: Screening (Day -28 to Day -2), Check-in (Day -1), Days 1, 3, 4, 5, 6 and 10

  5. Part A (Single Dose Group A9): Incidence of physical examination abnormalities

    Measured: Check-in (Day -1), Days 6 and 10

  6. Part B (Multiple Dose Group B5): Incidence of 12-lead electrocardiogram (ECG) abnormalities

    Measured: Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 4, 7, 10, 19, 25, 28, 30 and 37

  7. Part B (Multiple Dose Group B5): Incidence of vital sign abnormalities

    Measured: Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 19, 22, 25, 28, 30 and 37

  8. Part B (Multiple Dose Group B5): Incidence of physical examination abnormalities

    Measured: Check-in (Day -2), Days 30, 33 and 37

  9. Part B (Multiple Dose Group B6): Incidence of 12-lead electrocardiogram (ECG) abnormalities

    Measured: Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 3, 8, 10, 15, 17, 22, 25, 29, 34 and End of Study (Day 41)

  10. Part B (Multiple Dose Group B6): Incidence of vital sign abnormalities

    Measured: Screening (Day -28 to Day -3), Check-in (Day -2), Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 25, 27, 29, 34, 38 and End of Study (Day 41)

  11. Part B (Multiple Dose Group B6): Incidence of physical examination abnormalities

    Measured: Check-in (Day -2), Days 34, 38 and End of Study (Day 41)

  12. Part B (Multiple Dose Group B5 and Multiple Dose Group B6): Incidence and severity of adverse events (AEs)

    Measured: Day 1 up to end of study (For Group B5, Day 37 and for Group B6, Day 41)

  13. Part B (Multiple Dose Group B5 and Multiple Dose Group B6): Incidence of clinical laboratory abnormalities

    Measured: Screening (Day -28), Check-in (Day-2), Days 7, 14, 21, 28, 34 and End of Study (Day 41)

Secondary outcomes (64)

  1. Part A (Single Dose Group A9): Plasma pharmacokinetic (PK) outcome endpoint of ERX1000, AUC0-t

    Measured: Day 1, 8 and 10

  2. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, AUC0-∞

    Measured: Day 1, 8 and 10

  3. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, AUC0-τ

    Measured: Day 1, 8 and 10

  4. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, Cmax

    Measured: Day 1, 8 and 10

  5. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, Ctrough

    Measured: Day 1, 8 and 10

  6. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, Tmax

    Measured: Day 1, 8 and 10

  7. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, time of last measurable concentration (tlast)

    Measured: Day 1, 8 and 10

  8. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, t1/2

    Measured: Day 1, 8 and 10

  9. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, apparent total plasma clearance (CL/F)

    Measured: Day 1, 8 and 10

  10. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, apparent volume of distribution (Vz/F)

    Measured: Day 1, 8 and 10

  11. Part A (Single Dose Group A9): Plasma PK outcome endpoint of ERX1000, accumulation ratio (AR).

    Measured: Day 1, 8 and 10

  12. Part A (Single Dose Group A9): Urine PK outcome endpoint of ERX1000, amount of drug excreted in urine over the sampling period (Aeu)

    Measured: Day 1

  13. Part A (Single Dose Group A9): Urine PK outcome endpoint of ERX1000, percentage of dose excreted in urine over the sampling interval (%Feu)

    Measured: Day 1

  14. Part A (Single Dose Group A9): Urine PK outcome endpoint of ERX1000, renal clearance (CLR)

    Measured: Day 1

  15. Part B (Multiple Dose Group B5): Plasma pharmacokinetic (PK) outcome endpoint of ERX1000, AUC0-t

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  16. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, AUC0-∞

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  17. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, AUC0-τ

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  18. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, Cmax

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  19. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, Ctrough

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  20. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, Tmax

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  21. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, time of last measurable concentration (tlast)

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  22. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, t1/2

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  23. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, apparent total plasma clearance (CL/F)

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  24. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, apparent volume of distribution (Vz/F)

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  25. Part B (Multiple Dose Group B5): Plasma PK outcome endpoint of ERX1000, accumulation ratio (AR).

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  26. Part B (Multiple Dose Group B5): Urine PK outcome endpoint of ERX1000, amount of drug excreted in urine over the sampling period (Aeu)

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  27. Part B (Multiple Dose Group B5): Urine PK outcome endpoint of ERX1000, percentage of dose excreted in urine over the sampling interval (%Feu)

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  28. Part B (Multiple Dose Group B5): Urine PK outcome endpoint of ERX1000, renal clearance (CLR)

    Measured: Days 1, 7, 10, 13, 19, 22, 25, 28, 31, 33 and 37

  29. Part B (Multiple Dose Group B6): Plasma pharmacokinetic (PK) outcome endpoint of ERX1000, AUC0-t

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  30. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, AUC0-∞

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  31. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, AUC0-τ

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  32. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, Cmax

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  33. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, Ctrough

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  34. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, Tmax

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  35. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, time of last measurable concentration (tlast)

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  36. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, t1/2

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  37. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, apparent total plasma clearance (CL/F)

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  38. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, apparent volume of distribution (Vz/F)

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  39. Part B (Multiple Dose Group B6): Plasma PK outcome endpoint of ERX1000, accumulation ratio (AR).

    Measured: Days 1, 8, 15, 22, 29, 36, 38 and End of Study (Day 41)

  40. Part B (Multiple Dose Group B6): Urine PK outcome endpoint of ERX1000, amount of drug excreted in urine over the sampling period (Aeu)

    Measured: Day 1 and Day 29

  41. Part B (Multiple Dose Group B6): Urine PK outcome endpoint of ERX1000, percentage of dose excreted in urine over the sampling interval (%Feu)

    Measured: Day 1 and Day 29

  42. Part B (Multiple Dose Group B6): Urine PK outcome endpoint of ERX1000, renal clearance (CLR)

    Measured: Day 1 and Day 29

  43. Part B (Multiple Dose Group B5): Pharmacodynamic (PD) outcome endpoint of ERX1000, body weight

    Measured: Screening (Day -28 to Day -3), Days -1, 8, 15, 22, 28, 30, 33 and 37

  44. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, serum leptin

    Measured: Days -1, 7, 14, 21, 27 and 30

  45. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, serum lipid - High-density lipoprotein cholesterol (HDL)

    Measured: Days -1, 14 and 27

  46. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, serum lipid - Low-density lipoprotein cholesterol (LDL)

    Measured: Days -1, 14 and 27

  47. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, serum lipid -Total cholesterol

    Measured: Days -1, 14 and 27

  48. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, serum lipid - Triglyceride

    Measured: Days -1, 14 and 27

  49. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, serum insulin

    Measured: Days 7 and 21

  50. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, assessment derived from oral glucose tolerance test (OGTT) - serum glucose

    Measured: Days -1, 14 and 27

  51. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, assessment derived from oral glucose tolerance test (OGTT) - serum insulin

    Measured: Days -1, 14 and 27

  52. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, derived from oral glucose tolerance test (OGTT) - Homeostatic Model Assessment of Insulin Resistance

    Measured: Days -1, 14 and 27

  53. Part B (Multiple Dose Group B5): PD outcome endpoint of ERX1000, assessments derived from oral glucose tolerance test (OGTT) - Matsuda Index

    Measured: Days -1, 14 and 27

  54. Part B (Multiple Dose Group B6):Pharmacodynamic (PD) outcome endpoint of ERX1000, body weight

    Measured: Screening (Day -28 to -3), Days -1, 1, 8, 15, 22, 29, 34, 36, 38 and End of Study (Day 41)

  55. Part B (Multiple Dose Group B6):PD outcome endpoint of ERX1000, serum leptin

    Measured: Day -1 and Day 31

  56. Part B (Multiple Dose Group B6): PD outcome endpoint of ERX1000, serum lipid - High-density lipoprotein cholesterol (HDL)

    Measured: Day -1 and Day 31

  57. Part B (Multiple Dose Group B6): PD outcome endpoint of ERX1000, serum lipid - Low-density lipoprotein cholesterol (LDL)

    Measured: Day -1 and Day 31

  58. Part B (Multiple Dose Group B6): PD outcome endpoint of ERX1000, serum lipid -Total cholesterol

    Measured: Day -1 and Day 31

  59. Part B (Multiple Dose Group B6): PD outcome endpoint of ERX1000, serum lipid - Triglyceride

    Measured: Day -1 and Day 31

  60. Part B (Multiple Dose Group B6):PD outcome endpoint of ERX1000, serum insulin

    Measured: Day -1 and Day 31

  61. Part B (Multiple Dose Group B6):PD outcome endpoint of ERX1000, assessment derived from oral glucose tolerance test (OGTT) - serum glucose

    Measured: Day -1 and Day 31

  62. Part B (Multiple Dose Group B6):PD outcome endpoint of ERX1000, assessment derived from oral glucose tolerance test (OGTT) - serum insulin

    Measured: Day -1 and Day 31

  63. Part B (Multiple Dose Group B6):PD outcome endpoint of ERX1000, assessment derived from oral glucose tolerance test (OGTT) - Homeostatic Model Assessment of Insulin Resistance

    Measured: Day -1 and Day 31

  64. Part B (Multiple Dose Group B6):PD outcome endpoint of ERX1000, assessments derived from oral glucose tolerance test (OGTT) - Matsuda Index

    Measured: Day -1 and Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start17 Oct 2019
  3. Primary completion3 Jul 2023
  4. Study completion3 Jul 2023

Resources

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, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04890873
Sponsor's protocol ID
ERX1000-C-002
Status last verified
Oct 2023
First submitted
7 May 2021
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ERX1000 in people with Obesity, run by ERX Pharmaceuticals 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 11 inclusion and 35 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 24 Oct 2023. 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?

Part A (Single Dose Group A9): Incidence and severity of adverse events (AEs) (time frame: Day 1 up to end of study (Day 10)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04890873.

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 24 Oct 2023.

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