Trial Outcomes & Findings for Study to Evaluate ARD-101 in Adults With Obesity (NCT NCT05121441)
NCT ID: NCT05121441
Last Updated: 2025-01-22
Results Overview
The percent total weight change at the end of treatment from baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Run-in Visit (baseline), Day 28
Results posted on
2025-01-22
Participant Flow
Participants were recruited based on physician referrals at the clinical site between November 2021 and August 2022. A total of 30 subjects were originally planned, but only 20 subjects were enrolled, treated, and analyzed. The first participant was enrolled on November 15, 2021, and the last participant was enrolled in August 2022.
A total of 20 subjects were enrolled and all 20 (100%) subjects completed the study.
Participant milestones
| Measure |
ARD-101
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate ARD-101 in Adults With Obesity
Baseline characteristics by cohort
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 12 • n=5 Participants
|
49 years
STANDARD_DEVIATION 9 • n=7 Participants
|
55 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Weight
|
95.4 Kg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
101.6 Kg
STANDARD_DEVIATION 23.8 • n=7 Participants
|
97.3 Kg
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
BMI
|
34.1 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
35.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
34.5 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Run-in Visit (baseline), Day 28The percent total weight change at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Relative Change in Body Weight (%)
|
-0.33 Percentage of body weight change
Standard Deviation 0.94
|
0.38 Percentage of body weight change
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Days 1-28The number of treatment-emergent adverse events (TEAE) reported by participants during the treatment period
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Incidence (Number) of Treatment-emergent Adverse Events (TEAE)
Acid reflux
|
1 Participants
|
0 Participants
|
|
Incidence (Number) of Treatment-emergent Adverse Events (TEAE)
Nausea
|
1 Participants
|
0 Participants
|
|
Incidence (Number) of Treatment-emergent Adverse Events (TEAE)
No TEAE reported
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Days 1 to 28The change in total cholesterol (TC) at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Change in TC
|
-4.4 mg/dL
Standard Deviation 17.32
|
5.7 mg/dL
Standard Deviation 19.31
|
SECONDARY outcome
Timeframe: Days 1-28The change in triglyceride (TG) at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Change in TG
|
-0.6 mg/dL
Standard Deviation 93.81
|
0.5 mg/dL
Standard Deviation 27.60
|
SECONDARY outcome
Timeframe: Days 1-28The change in high density lipoprotein cholesterol (HDL) at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Change in HDL
|
0.2 mg/dL
Standard Deviation 7.36
|
4.0 mg/dL
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Days 1-28The change in low-density lipoprotein cholesterol (LDL) at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=13 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Change in LDL
|
-6.8 mg/dL
Standard Deviation 16.95
|
1.3 mg/dL
Standard Deviation 15.15
|
SECONDARY outcome
Timeframe: Days 1-28The change in waist circumference at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Change in Waist Circumference
|
-0.2 cm
Standard Deviation 1.7
|
-0.8 cm
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Screening to Day 28The change in % of hemoglobin A1c (HbA1c) at the end of treatment from baseline
Outcome measures
| Measure |
ARD-101
n=14 Participants
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 Participants
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Change in % HbA1C
|
-0.17 Percent of HbA1c
Standard Deviation 0.22
|
-0.18 Percent of HbA1c
Standard Deviation 0.24
|
Adverse Events
ARD-101
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARD-101
n=14 participants at risk
Dose 200 mg of ARD-101, twice daily for 28 days
ARD-101: Twice daily, oral administration
|
Placebo Comparator
n=6 participants at risk
Placebo arm matching active arm ARD-101, 200 mg BID
Placebo: Twice daily, oral administration
|
|---|---|---|
|
Gastrointestinal disorders
Acid Reflux
|
7.1%
1/14 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
0.00%
0/6 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
1/14 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
0.00%
0/6 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
0.00%
0/6 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
|
Injury, poisoning and procedural complications
Foot Injury
|
0.00%
0/14 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
16.7%
1/6 • Six weeks (28-day treatment period plus 14-day follow-up post treatment)
|
Additional Information
Manasi Jaiman MD, MPH, Chief Medical Officer
Aardvark Therapeutics, Inc.
Phone: (858) 225-7696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place