Trial Outcomes & Findings for Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia (NCT NCT05237960)
NCT ID: NCT05237960
Last Updated: 2026-09-02
Results Overview
Histologic response will be evaluated by the following criteria: complete response (CR): Complete reversal of dysplasia or hyperplasia to normal epithelium in the target lesion. Partial response (PR): Improvement of the degree of dysplasia or hyperplasia in the target lesion. No change (NC): No change in the degree of dysplasia or hyperplasia in the target lesion, anything that is not CR, PR or PD. Progressive disease (PD): Increase in the severity of grade of histology in the target lesion. Histologic response is CR or PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2026-09-02
Participant Flow
Of 76 potential contacted subjects, 37 were not eligible, and 5 withdrew after consenting, yielding 34 enrolled. All 34 were randomized, and all began treatment.
Participant milestones
| Measure |
Arm I (Extended Release Metformin)
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Baseline characteristics by cohort
| Measure |
Arm I (Extended Release Metformin)
n=17 Participants
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=17 Participants
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 8.3 • n=136 Participants
|
63.7 years
STANDARD_DEVIATION 11.4 • n=136 Participants
|
66.9 years
STANDARD_DEVIATION 10.4 • n=272 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=136 Participants
|
11 Participants
n=136 Participants
|
20 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=136 Participants
|
6 Participants
n=136 Participants
|
14 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=136 Participants
|
17 Participants
n=136 Participants
|
32 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=136 Participants
|
16 Participants
n=136 Participants
|
33 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Histology
Hyperplasia
|
2 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
|
Histology
Mild dysplasia
|
8 Participants
n=136 Participants
|
8 Participants
n=136 Participants
|
16 Participants
n=272 Participants
|
|
Histology
Moderate dysplasia
|
4 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
8 Participants
n=272 Participants
|
|
Histology
Severe dysplasia
|
3 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: 29 participants were on study long enough to be evaluable for the primary endpoint
Histologic response will be evaluated by the following criteria: complete response (CR): Complete reversal of dysplasia or hyperplasia to normal epithelium in the target lesion. Partial response (PR): Improvement of the degree of dysplasia or hyperplasia in the target lesion. No change (NC): No change in the degree of dysplasia or hyperplasia in the target lesion, anything that is not CR, PR or PD. Progressive disease (PD): Increase in the severity of grade of histology in the target lesion. Histologic response is CR or PR.
Outcome measures
| Measure |
Arm I (Extended Release Metformin)
n=15 Participants
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=14 Participants
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Histologic Response to Metformin
Responder (CR or PR)
|
9 Participants
|
7 Participants
|
|
Histologic Response to Metformin
Non-responder (NC or PD)
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: 29 participants were on study long enough to be evaluable for this secondary endpoint
Clinical response will be evaluated by the following criteria: CR: disappearance of all evidence of lesion(s). PR: greater than or equal to 50% reduction in the sum of the products of diameters of lesion(s) measurable at baseline. Non-measurable lesion(s) may not increase greater than or equal to 25% in size and no new lesion may appear. NC: no change in the size of the lesion(s) identified at baseline and no new lesions appearing, i.e., anything that is not CR, PR, or PD. PD: any increase greater than or equal to 25% in the product of the diameters of any lesion(s) measurable at baseline or in the estimated size of lesion(s) nonmeasurable at baseline or the appearance of an unequivocal new lesion. Clinical response is CR or PR.
Outcome measures
| Measure |
Arm I (Extended Release Metformin)
n=15 Participants
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=14 Participants
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Clinical Response to Metformin
Response (CR or PR)
|
7 Participants
|
6 Participants
|
|
Clinical Response to Metformin
Non-response (NC or PD)
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksEffect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion. The change (pre to post) will be compared between arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: 31 participants were on study long enough to be evaluable for serum metabolic marker endpoints.
Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c). The change (pre to post) in serum metabolic markers will be compared between arms.
Outcome measures
| Measure |
Arm I (Extended Release Metformin)
n=16 Participants
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=15 Participants
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Change in C-peptide
|
-32 pmol/L
Standard Deviation 200
|
75 pmol/L
Standard Deviation 151
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: 31 participants were on study long enough to be evaluable for serum metabolic marker endpoints.
Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c). The change (pre to post) in serum metabolic markers will be compared between arms.
Outcome measures
| Measure |
Arm I (Extended Release Metformin)
n=16 Participants
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=15 Participants
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Change in Glucose
|
-9 mg/dL
Standard Deviation 29
|
7 mg/dL
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: 31 participants were on study long enough to be evaluable for serum metabolic marker endpoints.
Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c). The change (pre to post) in serum metabolic markers will be compared between arms.
Outcome measures
| Measure |
Arm I (Extended Release Metformin)
n=16 Participants
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=15 Participants
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Change in HbA1C
|
-0.2 percent
Standard Deviation 0.5
|
0.1 percent
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: From baseline, up to 24 weeksThe plasma metformin concentrations will be determined in the pre- and post-intervention samples.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Extended Release Metformin)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Extended Release Metformin)
n=17 participants at risk
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=17 participants at risk
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
Other adverse events
| Measure |
Arm I (Extended Release Metformin)
n=17 participants at risk
Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
Arm II (Placebo)
n=17 participants at risk
Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 4 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Bloating
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 4 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Diarrhea
|
52.9%
9/17 • Number of events 17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
17.6%
3/17 • Number of events 5 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
1/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • Number of events 14 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Soft stool
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Tongue pain
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Stomach pain
|
17.6%
3/17 • Number of events 4 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
General disorders
Fatigue
|
17.6%
3/17 • Number of events 3 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
General disorders
Neck edema
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Stye
|
5.9%
1/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Tooth infection
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Injury, poisoning and procedural complications
Wasp sting
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Cholesterol high
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Hemoglobin increased
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Decreased ALT
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Decreased blood urea nitrogen
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Decreased creatinine
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Investigations
Blood in stool
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.8%
2/17 • Number of events 5 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Musculoskeletal and connective tissue disorders
Swollen sore knuckles
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Akathisia
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
17.6%
3/17 • Number of events 3 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 4 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
17.6%
3/17 • Number of events 6 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Syncope
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Nervous system disorders
Insomnia
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
11.8%
2/17 • Number of events 2 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Surgical and medical procedures
Colonoscopy
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
5.9%
1/17 • Number of events 1 • From enrollment through the Follow-up Visit which will occur 2-4 weeks after completion of the 24-week intervention period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60