Trial Outcomes & Findings for Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery (NCT NCT05215847)

Results Overview

The percent total weight change at the end of treatment from baseline

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2025-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	ARD-101 Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ARD-101 Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARD-101 n=11 Participants Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration
Age, Continuous	41 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Weight	117.9 Kilograms STANDARD_DEVIATION 21.8 • n=5 Participants
Body Mass Index (BMI)	42.7 kg/m^2 STANDARD_DEVIATION 4.98 • n=5 Participants
Height	165.6 Centimeter STANDARD_DEVIATION 9.7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: Participants that have completed dosing with ARD-101.

The percent total weight change at the end of treatment from baseline

Outcome measures

Outcome measures
Measure	ARD-101 n=11 Participants ARD-101 200 mg, orally twice daily for 28 days
Relative Change in Body Weight (%)	0.033 Percent Change Standard Deviation 1.515

SECONDARY outcome

Timeframe: Days 1-28

Population: Safety analysis set. All participants that have been dosed with ARD-101.

The incidence of treatment-emergent adverse events (TEAE) during the treatment period

Outcome measures

Outcome measures
Measure	ARD-101 n=12 Participants ARD-101 200 mg, orally twice daily for 28 days
Incidence of Treatment-emergent Adverse Events (TEAE)	6 Participants

SECONDARY outcome

Timeframe: Run-in Visit (baseline), Day 28

Population: All subjects who completed dosing of ARD-101.

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

Outcome measures

Outcome measures
Measure	ARD-101 n=11 Participants ARD-101 200 mg, orally twice daily for 28 days
Change in Blood Lipid Concentrations Total Cholesterol	-0.73 mg/dL Standard Deviation 18.23
Change in Blood Lipid Concentrations Triglyceride	2.09 mg/dL Standard Deviation 32.14
Change in Blood Lipid Concentrations High density lipoprotein cholesterol	-0.82 mg/dL Standard Deviation 9.36
Change in Blood Lipid Concentrations Low-density lipoprotein cholesterol	-0.36 mg/dL Standard Deviation 15.58

SECONDARY outcome

Timeframe: Baseline and Day 28

Population: One participant was removed from waist circumference analysis due to improper measurement documentation by the study site.

The change in waist circumference from baseline to end of treatment

Outcome measures

Outcome measures
Measure	ARD-101 n=10 Participants ARD-101 200 mg, orally twice daily for 28 days
Change in Waist Circumference	-0.7 Centimeters Standard Deviation 1.03

SECONDARY outcome

Timeframe: Screening (baseline), Day 28

Population: One subject did not have their HbA1c collected/documented, so no data was provided to include in analysis.

The change in glycated hemoglobin (HbA1c) at the end of treatment from the baseline

Outcome measures

Outcome measures
Measure	ARD-101 n=10 Participants ARD-101 200 mg, orally twice daily for 28 days
Change in Hemoglobin A1c	0.04 Percentage Standard Deviation 0.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Proportion of subjects who lose \< 5% and ≥ 5% initial weight

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 1, Day 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of interleukin (IL)-1 beta (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of IL-6 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of IL-10 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of IL-12 p40 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of IL-12 p70 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of IL-17 (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of tumor necrosis factor (TNF)-alpha (pg/mL) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Circulating levels of C reactive protein (CRP) (mg/L) at run in visit and end of treatment (day 28) performed during the MMTT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Days 1-28

Body fat percentage measured by bioelectrical impedance scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Change in the percentage of liver fat content assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

The change in homeostatic model assessment for insulin resistance (HOMA-IR) at the end of treatment from the baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

The change in fasting blood glucose at the end of treatment from the baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Change in serum bile acids at the end of treatment compared to the baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline)

Phenotypic taste test (using commercially available test strips) at baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Days 1, 15, and 28

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1, Day 28

Change in indirect calorimetry between Day 1 and Day 28

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Changes in AUC of serum level of glucose (mg/dL) during MMTT between baseline and Day 28

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Changes in AUC of serum level of insulin (uIU/mL) during MMTT between baseline and Day 28

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Run-in Visit (baseline), Day 28

Changes in AUC of serum levels of C-peptide (ng/mL) during MMTT between baseline and Day 28

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1, Day 28

Changes in fecal microbial species and their relative abundance assessed by 16S rRNA gene sequencing

Outcome measures

Outcome data not reported

Adverse Events

ARD-101

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ARD-101 n=12 participants at risk Dose 200 mg of ARD-101, twice daily for 28 days ARD-101: Twice daily, oral administration
Gastrointestinal disorders Mild Nausea	16.7% 2/12 • Number of events 2 • 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.
Gastrointestinal disorders Mild Emesis	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations Mild Common Cold	8.3% 1/12 • Number of events 1 • 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.
Nervous system disorders Mild Headache	8.3% 1/12 • Number of events 2 • 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.
Gastrointestinal disorders Mild Constipation	8.3% 1/12 • Number of events 1 • 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.
Gastrointestinal disorders Mild Heart Burn	8.3% 1/12 • Number of events 1 • 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.
Endocrine disorders Mild Hypoglycemia	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations Mild COVID-19	8.3% 1/12 • Number of events 1 • 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.
Gastrointestinal disorders Mild Dyspepsia	8.3% 1/12 • Number of events 1 • 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.

Additional Information

Manasi Jaiman MD, MPH, Chief Medical Officer

Aardvark Therapeutics

Phone: (858) 225-7696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place