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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).
This is a Phase 2, open-label study to investigate the safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass). This study has a planned enrollment of 30 subjects (approximately 15 for each preceding surgical procedure) and will be conducted in a single center in the United States.
The study will consist of a Screening Period (up to 28 days), a Treatment Period (28 days), and a Follow-up Period (EOS Visit within 14 days after receiving the last dose of ARD-101). The screening procedures will be initiated upon completion of the informed consent process. Following completion of screening procedures and confirmation of eligibility, subjects will be enrolled to receive ARD-101.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARD-101 | Experimental | Dose 200 mg of ARD-101, twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARD-101 | Drug | Twice daily, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Body Weight (%) | The percent total weight change at the end of treatment from baseline | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAE) | The incidence of treatment-emergent adverse events (TEAE) during the treatment period | Days 1-28 |
| Change in Blood Lipid Concentrations | The change in blood lipid concentrations (total cholesterol, triglyceride, high density lipoprotein cholesterol, and low-density lipoprotein cholesterol) at the end of treatment from the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Categorical Weight Loss | Proportion of subjects who lose < 5% and ≥ 5% initial weight | Run-in Visit (baseline), Day 28 |
| Circulating Levels of Glucagon-like Peptide (GLP)-1 (Pmol) During Mixed-Meal Tolerance Test (MMTT) at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 |
Inclusion Criteria:
Male and female subjects, 18-75 years of age
Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
Body Mass Index (BMI) of 35-60 kg/m2 during the Screening Period
Status of at least 1-year post sleeve gastrectomy or gastric bypass surgery. Subjects must have a documented weight loss of at least 50% of their excess weight at their nadir, and must have regained at least 20% of their nadir weight loss. Excess weight is defined as maximum preoperative weight - weight corresponding to a BMI of 25 kg/m2
Subjects with rescue surgery (e.g. gastric band to sleeve gastrectomy or gastric bypass; sleeve gastrectomy to gastric bypass) will be allowed, with time since second surgery of at least 12 months.
Subjects with a history of revision procedures will be allowed if at least 6 months have passed since the procedure and weight has not deviated more than 5% in the 3 months prior to enrollment
No abnormal findings or abnormalities of clinical significance in vital signs, physical examination, clinical laboratory tests (CBC, urinalysis, blood biochemistry, coagulation, pregnancy test (females), urine drug test, nicotine test, etc.), 12-lead electrocardiogram (ECG) during the Screening Period
Serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and total bilirubin (unless the subject has documented Gilbert syndrome) not exceeding 1.5-fold the upper laboratory norm and estimated Glomerular Filtration Rate (eGFR) >30 mL/min
Standard 12-lead ECG parameters after 10minutes resting in supine position in the following ranges; 120 ms <PR <220 ms, QRS <120 ms, QTc <= 430 ms if male, <= 450 ms if female and normal ECG tracing unless the Investigator considers an ECG abnormality within described limits to be not clinically relevant
Stable or well controlled blood pressure per Investigator's judgement during the Screening Period. Specifically: Vital signs after 10 minutes sitting in a chair (feet on floor, back supported):
i. 95 mmHg < systolic blood pressure (SBP) <160 mmHg, ii. 45 mm Hg < diastolic blood pressure (DBP) <100 mm Hg, iii. 40 bpm < heart rate (HR) <100 bpm.
Prediabetes- defined as a fasting blood glucose between 100-125 mg/dL OR an HbA1c between 5.7-6.5% at screening
Type 2 diabetes- Defined as previous diagnosis by a healthcare professional OR a fasting blood glucose > 126 mg/dL OR HbA1c > 6.5% at screening.
Patients with type 2 diabetes treated with metformin may be enrolled. However, patients with type 2 diabetes on any other therapy will be excluded.
Female subjects must have negative serum pregnancy test and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single barrier method (i.e., sponge), or a double-barrier method of birth control (i.e., condom with spermicide) or abstinence must be used/practiced throughout the study and for 90 days following last dose of study medication; for effective form of birth control.
Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusion) or post-menopausal for at least 12 months (may be confirmed with a screening follicle stimulating hormone (FSH) level in the post-menopausal lab range), do not require contraception during the study.
Males with female partners of childbearing potential must agree to a double-barrier method if participants become sexually active during the study and for 90 days following the last dose of the study medication. Male subjects must not donate sperm for 90 days following their participation in the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute, University of California, San Diego | San Diego | California | 92037 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARD-101 | Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who completed treatment of ARD-101
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| ID | Title | Description |
|---|---|---|
| BG000 | ARD-101 | Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Change in Body Weight (%) | The percent total weight change at the end of treatment from baseline | Participants that have completed dosing with ARD-101. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Day 28 |
|
|
12 weeks
Any untoward event occurring in the clinical study framework was documented and recorded as an adverse event, including those occurring during treatment-free periods (including screening or post-treatment follow-up periods). Adverse event monitoring was performed and collected at screening, Day 1 (predose), Day 15, Day 28, and follow-up/end of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARD-101 | Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Nausea | Gastrointestinal disorders | Systematic Assessment | Related, no action was taken, resolved without sequelae |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manasi Jaiman MD, MPH, Chief Medical Officer | Aardvark Therapeutics | (858) 225-7696 | MJaiman@aardvarktherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2022 | Oct 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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This study includes one intervention arm.
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| Run-in Visit (baseline), Day 28 |
| Change in Waist Circumference | The change in waist circumference from baseline to end of treatment | Baseline and Day 28 |
| Change in Hemoglobin A1c | The change in glycated hemoglobin (HbA1c) at the end of treatment from the baseline | Screening (baseline), Day 28 |
Circulating levels of glucagon-like peptide (GLP)-1 (pmol) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for mixed-meal tolerance test (MMTT) at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. |
| Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Cholecystokinin (CCK) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of cholecystokinin (CCK) (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Peptide YY (PYY) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of peptide YY (PYY) (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Amylin (Pmol) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of amylin (pmol) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Glucose-dependent Insulinotropic Polypeptide (GIP) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of glucose-dependent insulinotropic polypeptide (GIP) (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Ghrelin (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of ghrelin (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Leptin (ng/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of leptin (ng/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Adiponectin (mcg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of adiponectin (mcg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Circulating Levels of Glucagon (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of glucagon (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Run-in Visit (baseline), Day 1, Day 28 |
| Serum Levels of Glucose (mg/dL) During MMTT at Baseline and on Day 28 | Serum levels of glucose (mg/dL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Run-in Visit (baseline), Day 28 |
| Serum Levels of Insulin (uIU/mL) During MMTT at Baseline and on Day 28 | Serum levels of insulin (uIU/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Run-in Visit (baseline), Day 28 |
| Serum Levels of C-peptide (ng/mL) During MMTT at Baseline and on Day 28 | Serum levels of C-peptide (ng/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Run-in Visit (baseline), Day 28 |
| Serum Levels of Free Fatty Acids During MMTT at Baseline and on Day 28 | Serum levels of free fatty acids (FFA) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Run-in Visit (baseline), Day 28 |
| Circulating Levels of Interleukin (IL)-1 Beta (pg/mL) During MMTT | Circulating levels of interleukin (IL)-1 beta (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of IL-6 (pg/mL) During MMTT | Circulating levels of IL-6 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of IL-10 (pg/mL) During MMTT | Circulating levels of IL-10 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of IL-12 p40 (pg/mL) During MMTT | Circulating levels of IL-12 p40 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of IL-12 p70 (pg/mL) During MMTT | Circulating levels of IL-12 p70 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of IL-17 (pg/mL) During MMTT | Circulating levels of IL-17 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of Tumor Necrosis Factor (TNF)-Alpha (pg/mL) During MMTT | Circulating levels of tumor necrosis factor (TNF)-alpha (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Circulating Levels of C Reactive Protein (CRP) (mg/L) During MMTT | Circulating levels of C reactive protein (CRP) (mg/L) at run in visit and end of treatment (day 28) performed during the MMTT | Run-in Visit (baseline), Day 28 |
| Body Fat Percentage | Body fat percentage measured by bioelectrical impedance scale | Run-in Visit (baseline), Days 1-28 |
| Change in the Percentage of Liver Fat Content | Change in the percentage of liver fat content assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) | Run-in Visit (baseline), Day 28 |
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | The change in homeostatic model assessment for insulin resistance (HOMA-IR) at the end of treatment from the baseline | Run-in Visit (baseline), Day 28 |
| Change in Fasting Blood Glucose | The change in fasting blood glucose at the end of treatment from the baseline | Run-in Visit (baseline), Day 28 |
| Change in Serum Bile Acids | Change in serum bile acids at the end of treatment compared to the baseline | Run-in Visit (baseline), Day 28 |
| Phenotypic Taste Test | Phenotypic taste test (using commercially available test strips) at baseline | Run-in Visit (baseline) |
| Control of Eating and Food Cravings | Control of eating and food craving assessed by the Control of Eating Questionnaire (CoEQ), which is a 21-item questionnaire designed to assess the intensity and type of food cravings and subjective sensations of appetite and mood according to an individual's experience over the last 7 days. Items on the CoEQ are assessed by 100-mm visual analogue scales (VAS). Subjects will mark their level with a vertical line on the horizontal line of the VAS scale. The numerical value will start at 1.0 cm and end 10.0 cm. Use a ruler to determine the numerical value (to the tenth decimal) associated with the line marked by subjects. Higher score indicates less control of eating and food cravings. | Screening, Days 1, 15, and 28 |
| Change in Indirect Calorimetry | Change in indirect calorimetry between Day 1 and Day 28 | Day 1, Day 28 |
| Area Under the Curve (AUC) of Serum Level of Glucose (mg/dL) During MMTT | Changes in AUC of serum level of glucose (mg/dL) during MMTT between baseline and Day 28 | Run-in Visit (baseline), Day 28 |
| Area Under the Curve (AUC) of Serum Level of Insulin (uIU/mL) During MMTT | Changes in AUC of serum level of insulin (uIU/mL) during MMTT between baseline and Day 28 | Run-in Visit (baseline), Day 28 |
| Area Under the Curve (AUC) of Serum Level of C-peptide (ng/mL) During MMTT | Changes in AUC of serum levels of C-peptide (ng/mL) during MMTT between baseline and Day 28 | Run-in Visit (baseline), Day 28 |
| Changes in Fecal Microbial Species and Their Relative Abundance | Changes in fecal microbial species and their relative abundance assessed by 16S rRNA gene sequencing | Day 1, Day 28 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | Centimeter |
|
|
| Secondary | Incidence of Treatment-emergent Adverse Events (TEAE) | The incidence of treatment-emergent adverse events (TEAE) during the treatment period | Safety analysis set. All participants that have been dosed with ARD-101. | Posted | Count of Participants | Participants | Days 1-28 |
|
|
|
|
| Secondary | Change in Blood Lipid Concentrations | The change in blood lipid concentrations (total cholesterol, triglyceride, high density lipoprotein cholesterol, and low-density lipoprotein cholesterol) at the end of treatment from the baseline | All subjects who completed dosing of ARD-101. | Posted | Mean | Standard Deviation | mg/dL | Run-in Visit (baseline), Day 28 |
|
|
|
| Secondary | Change in Waist Circumference | The change in waist circumference from baseline to end of treatment | One participant was removed from waist circumference analysis due to improper measurement documentation by the study site. | Posted | Mean | Standard Deviation | Centimeters | Baseline and Day 28 |
|
|
|
| Secondary | Change in Hemoglobin A1c | The change in glycated hemoglobin (HbA1c) at the end of treatment from the baseline | One subject did not have their HbA1c collected/documented, so no data was provided to include in analysis. | Posted | Mean | Standard Deviation | Percentage | Screening (baseline), Day 28 |
|
|
|
| Other Pre-specified | Categorical Weight Loss | Proportion of subjects who lose < 5% and ≥ 5% initial weight | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Glucagon-like Peptide (GLP)-1 (Pmol) During Mixed-Meal Tolerance Test (MMTT) at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of glucagon-like peptide (GLP)-1 (pmol) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for mixed-meal tolerance test (MMTT) at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Cholecystokinin (CCK) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of cholecystokinin (CCK) (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Peptide YY (PYY) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of peptide YY (PYY) (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Amylin (Pmol) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of amylin (pmol) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Glucose-dependent Insulinotropic Polypeptide (GIP) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of glucose-dependent insulinotropic polypeptide (GIP) (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Ghrelin (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of ghrelin (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Leptin (ng/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of leptin (ng/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Adiponectin (mcg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of adiponectin (mcg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Glucagon (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1 | Circulating levels of glucagon (pg/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28, and pre-dosing and 1 and 2 hours post the first dosing on day 1. | Not Posted | Run-in Visit (baseline), Day 1, Day 28 | Participants |
| Other Pre-specified | Serum Levels of Glucose (mg/dL) During MMTT at Baseline and on Day 28 | Serum levels of glucose (mg/dL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Serum Levels of Insulin (uIU/mL) During MMTT at Baseline and on Day 28 | Serum levels of insulin (uIU/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Serum Levels of C-peptide (ng/mL) During MMTT at Baseline and on Day 28 | Serum levels of C-peptide (ng/mL) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Serum Levels of Free Fatty Acids During MMTT at Baseline and on Day 28 | Serum levels of free fatty acids (FFA) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT at baseline (run-in visit) and on day 28. | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Interleukin (IL)-1 Beta (pg/mL) During MMTT | Circulating levels of interleukin (IL)-1 beta (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of IL-6 (pg/mL) During MMTT | Circulating levels of IL-6 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of IL-10 (pg/mL) During MMTT | Circulating levels of IL-10 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of IL-12 p40 (pg/mL) During MMTT | Circulating levels of IL-12 p40 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of IL-12 p70 (pg/mL) During MMTT | Circulating levels of IL-12 p70 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of IL-17 (pg/mL) During MMTT | Circulating levels of IL-17 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of Tumor Necrosis Factor (TNF)-Alpha (pg/mL) During MMTT | Circulating levels of tumor necrosis factor (TNF)-alpha (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Circulating Levels of C Reactive Protein (CRP) (mg/L) During MMTT | Circulating levels of C reactive protein (CRP) (mg/L) at run in visit and end of treatment (day 28) performed during the MMTT | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Body Fat Percentage | Body fat percentage measured by bioelectrical impedance scale | Not Posted | Run-in Visit (baseline), Days 1-28 | Participants |
| Other Pre-specified | Change in the Percentage of Liver Fat Content | Change in the percentage of liver fat content assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | The change in homeostatic model assessment for insulin resistance (HOMA-IR) at the end of treatment from the baseline | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Change in Fasting Blood Glucose | The change in fasting blood glucose at the end of treatment from the baseline | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Change in Serum Bile Acids | Change in serum bile acids at the end of treatment compared to the baseline | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Phenotypic Taste Test | Phenotypic taste test (using commercially available test strips) at baseline | Not Posted | Run-in Visit (baseline) | Participants |
| Other Pre-specified | Control of Eating and Food Cravings | Control of eating and food craving assessed by the Control of Eating Questionnaire (CoEQ), which is a 21-item questionnaire designed to assess the intensity and type of food cravings and subjective sensations of appetite and mood according to an individual's experience over the last 7 days. Items on the CoEQ are assessed by 100-mm visual analogue scales (VAS). Subjects will mark their level with a vertical line on the horizontal line of the VAS scale. The numerical value will start at 1.0 cm and end 10.0 cm. Use a ruler to determine the numerical value (to the tenth decimal) associated with the line marked by subjects. Higher score indicates less control of eating and food cravings. | Not Posted | Screening, Days 1, 15, and 28 | Participants |
| Other Pre-specified | Change in Indirect Calorimetry | Change in indirect calorimetry between Day 1 and Day 28 | Not Posted | Day 1, Day 28 | Participants |
| Other Pre-specified | Area Under the Curve (AUC) of Serum Level of Glucose (mg/dL) During MMTT | Changes in AUC of serum level of glucose (mg/dL) during MMTT between baseline and Day 28 | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Area Under the Curve (AUC) of Serum Level of Insulin (uIU/mL) During MMTT | Changes in AUC of serum level of insulin (uIU/mL) during MMTT between baseline and Day 28 | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Area Under the Curve (AUC) of Serum Level of C-peptide (ng/mL) During MMTT | Changes in AUC of serum levels of C-peptide (ng/mL) during MMTT between baseline and Day 28 | Not Posted | Run-in Visit (baseline), Day 28 | Participants |
| Other Pre-specified | Changes in Fecal Microbial Species and Their Relative Abundance | Changes in fecal microbial species and their relative abundance assessed by 16S rRNA gene sequencing | Not Posted | Day 1, Day 28 | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
|
| Mild Emesis | Gastrointestinal disorders | Systematic Assessment | Related, no action was taken, resolved without sequelae |
|
| Mild Common Cold | Infections and infestations | Systematic Assessment | No related, concomitant therapy intervention, resolved without sequelae |
|
| Mild Headache | Nervous system disorders | Systematic Assessment | Related, no action was taken, resolved without sequelae |
|
| Mild Constipation | Gastrointestinal disorders | Systematic Assessment | Related, no action was taken, resolved without sequelae |
|
| Mild Heart Burn | Gastrointestinal disorders | Systematic Assessment | Related, no action was taken, resolved without sequelae |
|
| Mild Hypoglycemia | Endocrine disorders | Systematic Assessment | Not related, no action was taken, resolved without sequelae |
|
| Mild COVID-19 | Infections and infestations | Systematic Assessment | Not related, concomitant therapy intervention, resolved without sequelae |
|
| Mild Dyspepsia | Gastrointestinal disorders | Systematic Assessment | Related, no action was taken, resolved without sequelae |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Title | Measurements |
|---|---|
|
| Low-density lipoprotein cholesterol |
|