Trial · NCT03364335
The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
NCT03364335, Phase 2, Completed, NuSirt Biopharma; results first posted 2018-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity. Trials, record NCT03364335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03364335
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
- NCT number
- NCT03364335
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 267 participants, actual
- Lead sponsor
- NuSirt Biopharma
- Conditions
- Obesity
- Interventions
- Leu Sil 1.0mg, Leu Sil 4.0mg, Leu Met Sil 1.0mg, Leu Met Sil 4.0mg, Placebo
- First posted
- 2017-12-06
- Last updated
- 2019-08-21
- Results first posted
- 2018-11-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Body Weight Change | Baseline to Day 168 | The percentage body weight change from baseline to Day 168 was evaluated. |
| Secondary | Change in Absolute Body Weight | Baseline to Day 168 | The change in absolute body weight from baseline to day 168 was evaluated. |
| Secondary | Change in Percentage of Patients With ≥5% Body Weight Loss | Baseline to Day 168 | The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168. |
| Secondary | Change in Waist Circumference | Baseline to Day 168 | The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168. |
| Secondary | Change in Total Cholesterol | Baseline to Day 168 | Changes in total cholesterol was examined by standard blood chemistry. |
| Secondary | Change in HDL Cholesterol | Baseline, Day 168 | Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry. |
| Secondary | Change in LDL Cholesterol | Baseline, 168 days | Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168. |
| Secondary | Change in Triglycerides | Baseline, Day 168 | The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168. |
| Secondary | Change in Plasma Glucose | Baseline to Day 168 | Change in plasma glucose was examined through standard fasting blood chemistry. |
| Secondary | Change in Hemoglobin A1c (HbA1c) | Baseline, Day 168 | Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Body Weight Change | Baseline to Day 168 | ANCOVA Analysis for Primary Endpoint - Percent Change in Body Weight from Baseline to Day 168 in per protocol population. | percentage | MEAN |
| SECONDARY | Change in Absolute Body Weight | Baseline to Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population). | kg | MEAN |
| SECONDARY | Change in Percentage of Patients With ≥5% Body Weight Loss | Baseline to Day 168 | Analysis for Secondary Endpoint - Percentage of Subjects with ≥5% Relative Percentage Reduction from Baseline to day 168 in Body Weight by Treatment (Per-Protocol Population). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Waist Circumference | Baseline to Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Waist Circumference from Baseline (Per-Protocol Population). | cm | MEAN |
| SECONDARY | Change in Total Cholesterol | Baseline to Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | mg/dL | MEAN |
| SECONDARY | Change in HDL Cholesterol | Baseline, Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | mg/dL | MEAN |
| SECONDARY | Change in LDL Cholesterol | Baseline, 168 days | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | mg/dL | MEAN |
| SECONDARY | Change in Triglycerides | Baseline, Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | mg/dL | MEAN |
| SECONDARY | Change in Plasma Glucose | Baseline to Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population). | mg/dL | MEAN |
| SECONDARY | Change in Hemoglobin A1c (HbA1c) | Baseline, Day 168 | ANCOVA Analysis for Secondary Endpoint - Change in HbA1c from Baseline to day 168 (Per-Protocol Population). | percentage of glycosylated hemoglobin | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Body Weight Change | Placebo | 1.121 | Standard Deviation 3.6241 | percentage | |
| Percentage Body Weight Change | Leu Sil 1.0mg | 0.674 | Standard Deviation 3.2286 | percentage | |
| Percentage Body Weight Change | Leu Sil 4.0mg | -0.489 | Standard Deviation 3.9041 | percentage | |
| Percentage Body Weight Change | Leu Met Sil 1.0mg | -0.929 | Standard Deviation 4.5533 | percentage | |
| Percentage Body Weight Change | Leu Met Sil 4.0mg | -0.552 | Standard Deviation 2.5924 | percentage | |
| Change in Absolute Body Weight | Placebo | 1.126 | Standard Deviation 3.5903 | kg | |
| Change in Absolute Body Weight | Leu Sil 1.0mg | 0.678 | Standard Deviation 3.2502 | kg | |
| Change in Absolute Body Weight | Leu Sil 4.0mg | -0.460 | Standard Deviation 4.0352 | kg | |
| Change in Absolute Body Weight | Leu Met Sil 1.0mg | -0.870 | Standard Deviation 4.5445 | kg | |
| Change in Absolute Body Weight | Leu Met Sil 4.0mg | -0.461 | Standard Deviation 2.7583 | kg |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | STARTED | Leu Sil 1.0mg | 51 | |
| Overall Study | STARTED | Leu Sil 4.0mg | 53 | |
| Overall Study | STARTED | Leu Met Sil 1.0mg | 50 | |
| Overall Study | STARTED | Leu Met Sil 4.0mg | 52 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | COMPLETED | Leu Sil 1.0mg | 40 | |
| Overall Study | COMPLETED | Leu Sil 4.0mg | 42 | |
| Overall Study | COMPLETED | Leu Met Sil 1.0mg | 37 | |
| Overall Study | COMPLETED | Leu Met Sil 4.0mg | 41 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 52 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Leu Sil 1.0mg | 0 | 51 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Leu Sil 4.0mg | 1 | 53 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Leu Met Sil 1.0mg | 3 | 50 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Leu Met Sil 4.0mg | 1 | 52 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 0 | 52 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Leu Sil 1.0mg | 4 | 51 | 4 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Leu Sil 4.0mg | 0 | 53 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Leu Met Sil 1.0mg | 0 | 50 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Leu Met Sil 4.0mg | 0 | 52 | 0 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, all-cause mortality | Leu Sil 1.0mg | 0 | 51 |
| Total, all-cause mortality | Leu Sil 4.0mg | 0 | 53 |
| Total, all-cause mortality | Leu Met Sil 1.0mg | 0 | 50 |
| Total, all-cause mortality | Leu Met Sil 4.0mg | 0 | 52 |
| Total, other adverse events | Placebo | 14 | 52 |
| Total, other adverse events | Leu Sil 1.0mg | 19 | 51 |
| Total, other adverse events | Leu Sil 4.0mg | 12 | 53 |
| Total, other adverse events | Leu Met Sil 1.0mg | 21 | 50 |
| Total, other adverse events | Leu Met Sil 4.0mg | 19 | 52 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03364335
GET https://conductscience.org/api/trials/v1/NCT03364335/results?page=2