Trial Outcomes & Findings for Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists (NCT NCT06640972)
NCT ID: NCT06640972
Last Updated: 2026-07-02
Results Overview
Mean percent change in incremental TG area under the curve (AUC) from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-07-02
Participant Flow
Participant milestones
| Measure |
Investigational Drug
RDX-002 microsomal triglyceride transfer protein
|
Placebo
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Investigational Drug
RDX-002 microsomal triglyceride transfer protein
|
Placebo
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
Baseline characteristics by cohort
| Measure |
Investigational Drug
n=34 Participants
RDX-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 Participants
Matching placebo
Placebo: Matching placebo
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 10.67 • n=20 Participants
|
45.8 years
STANDARD_DEVIATION 11.58 • n=20 Participants
|
45.5 years
STANDARD_DEVIATION 11.05 • n=40 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
55 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
63 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=20 Participants
|
34 participants
n=20 Participants
|
68 participants
n=40 Participants
|
|
Weight
|
80.61 kilograms
STANDARD_DEVIATION 13.148 • n=20 Participants
|
83.21 kilograms
STANDARD_DEVIATION 20.617 • n=20 Participants
|
81.91 kilograms
STANDARD_DEVIATION 17.211 • n=40 Participants
|
|
Height
|
166.44 centimeters
STANDARD_DEVIATION 8.570 • n=20 Participants
|
167.66 centimeters
STANDARD_DEVIATION 7.927 • n=20 Participants
|
167.05 centimeters
STANDARD_DEVIATION 8.216 • n=40 Participants
|
|
BMI
|
29.09 kg/m2
STANDARD_DEVIATION 4.171 • n=20 Participants
|
29.51 kg/m2
STANDARD_DEVIATION 6.930 • n=20 Participants
|
29.30 kg/m2
STANDARD_DEVIATION 5.680 • n=40 Participants
|
|
Triglycerides
|
90.06 mg/dL
STANDARD_DEVIATION 40.821 • n=20 Participants
|
92.06 mg/dL
STANDARD_DEVIATION 41.924 • n=20 Participants
|
91.06 mg/dL
STANDARD_DEVIATION 41.078 • n=40 Participants
|
PRIMARY outcome
Timeframe: 12 weeksMean percent change in incremental TG area under the curve (AUC) from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Outcome measures
| Measure |
Investigational Drug
n=34 Participants
RTN-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Incremental Postprandial Triglycerides (TG)
|
-51.91 percent change
Standard Deviation 72.293
|
43.81 percent change
Standard Deviation 92.373
|
SECONDARY outcome
Timeframe: 12 weeksMean percent change in total postprandial TG AUC from baseline to week 12.Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Outcome measures
| Measure |
Investigational Drug
n=34 Participants
RTN-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Total Postprandial TG
|
-1.54 Percent change
Standard Deviation 30.212
|
12.14 Percent change
Standard Deviation 29.931
|
SECONDARY outcome
Timeframe: 12 weeksMean percent change in body weight from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Outcome measures
| Measure |
Investigational Drug
n=34 Participants
RTN-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
Body Weight
|
5.710 Percent change
Standard Deviation 4.703
|
8.364 Percent change
Standard Deviation 5.864
|
SECONDARY outcome
Timeframe: 12 weeksPercentage of patients exhibiting at least a 5% increase from baseline to Week 12.
Outcome measures
| Measure |
Investigational Drug
n=34 Participants
RTN-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
5% Increase in Body Weight
At least a 5% change
|
19 Participants
|
24 Participants
|
|
5% Increase in Body Weight
No 5% change
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 weeksMean percent change from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Outcome measures
| Measure |
Investigational Drug
n=34 Participants
RTN-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 Participants
Matching placebo
Placebo: Matching placebo
|
|---|---|---|
|
LDL-C
|
3.13 Percent change
Standard Deviation 21.619
|
6.50 Percent change
Standard Deviation 22.379
|
Adverse Events
Investigational Drug
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Drug
n=34 participants at risk
Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 participants at risk
Matching placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/34 • 12 weeks
|
2.9%
1/34 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Investigational Drug
n=34 participants at risk
Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
|
Placebo
n=34 participants at risk
Matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal extension
|
20.6%
7/34 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
6/34 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
14.7%
5/34 • 12 weeks
|
2.9%
1/34 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • 12 weeks
|
5.9%
2/34 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • 12 weeks
|
0.00%
0/34 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.6%
7/34 • 12 weeks
|
17.6%
6/34 • 12 weeks
|
|
Infections and infestations
COVID-19
|
5.9%
2/34 • 12 weeks
|
2.9%
1/34 • 12 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
2/34 • 12 weeks
|
2.9%
1/34 • 12 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.9%
1/34 • 12 weeks
|
11.8%
4/34 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • 12 weeks
|
5.9%
2/34 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/34 • 12 weeks
|
5.9%
2/34 • 12 weeks
|
|
Gastrointestinal disorders
diarrhoea
|
64.7%
22/34 • 12 weeks
|
5.9%
2/34 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
23.5%
8/34 • 12 weeks
|
5.9%
2/34 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place