Last reviewed · How we verify
The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
Phase 2 trial testing Leu Sil 1.0mg in Obesity in 267 participants. Completed in 17 August 2018.
| Lead sponsor | NuSirt Biopharma |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 267 |
| Start date | 8 January 2018 |
| Primary completion | 6 August 2018 |
| Estimated completion | 17 August 2018 |
| Sites | 15 locations across United States |
NuSirt Biopharma — full company profile →
Adults 18 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage body weight change from baseline to Day 168 was evaluated.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.121 | ± 3.6241 |
| Leu Sil 1.0mg | 0.674 | ± 3.2286 |
| Leu Sil 4.0mg | -0.489 | ± 3.9041 |
| Leu Met Sil 1.0mg | -0.929 | ± 4.5533 |
| Leu Met Sil 4.0mg | -0.552 | ± 2.5924 |
The change in absolute body weight from baseline to day 168 was evaluated.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.126 | ± 3.5903 |
| Leu Sil 1.0mg | 0.678 | ± 3.2502 |
| Leu Sil 4.0mg | -0.460 | ± 4.0352 |
| Leu Met Sil 1.0mg | -0.870 | ± 4.5445 |
| Leu Met Sil 4.0mg | -0.461 | ± 2.7583 |
The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2 | |
| Leu Sil 1.0mg | 1 | |
| Leu Sil 4.0mg | 6 | |
| Leu Met Sil 1.0mg | 7 | |
| Leu Met Sil 4.0mg | 3 |
The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.043 | ± 5.5591 |
| Leu Sil 1.0mg | 0.028 | ± 5.5152 |
| Leu Sil 4.0mg | -1.060 | ± 5.5564 |
| Leu Met Sil 1.0mg | -1.841 | ± 4.7654 |
| Leu Met Sil 4.0mg | 0.637 | ± 5.7908 |
Changes in total cholesterol was examined by standard blood chemistry.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.0 | ± 20.33 |
| Leu Sil 1.0mg | 0.2 | ± 20.96 |
| Leu Sil 4.0mg | 1.9 | ± 20.01 |
| Leu Met Sil 1.0mg | -0.7 | ± 16.74 |
| Leu Met Sil 4.0mg | -6.6 | ± 23.48 |
Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.1 | ± 7.43 |
| Leu Sil 1.0mg | 0.6 | ± 7.59 |
| Leu Sil 4.0mg | 2.4 | ± 6.40 |
| Leu Met Sil 1.0mg | 1.8 | ± 8.21 |
| Leu Met Sil 4.0mg | 1.6 | ± 7.72 |
Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -5.5 | ± 15.40 |
| Leu Sil 1.0mg | -6.6 | ± 16.86 |
| Leu Sil 4.0mg | -4.2 | ± 15.81 |
| Leu Met Sil 1.0mg | -5.5 | ± 11.77 |
| Leu Met Sil 4.0mg | -11.6 | ± 19.72 |
The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 13.4 | ± 45.43 |
| Leu Sil 1.0mg | 9.7 | ± 56.42 |
| Leu Sil 4.0mg | 1.9 | ± 51.93 |
| Leu Met Sil 1.0mg | -4.4 | ± 47.02 |
| Leu Met Sil 4.0mg | 3.5 | ± 52.03 |
Change in plasma glucose was examined through standard fasting blood chemistry.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.4 | ± 7.98 |
| Leu Sil 1.0mg | -1.6 | ± 9.35 |
| Leu Sil 4.0mg | 0.3 | ± 9.59 |
| Leu Met Sil 1.0mg | 1.1 | ± 12.43 |
| Leu Met Sil 4.0mg | -1.7 | ± 10.87 |
Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.16 | ± 0.164 |
| Leu Sil 1.0mg | 0.09 | ± 0.167 |
| Leu Sil 4.0mg | 0.11 | ± 0.165 |
| Leu Met Sil 1.0mg | 0.07 | ± 0.198 |
| Leu Met Sil 4.0mg | 0.09 | ± 0.177 |
Diastolic blood pressure was measured by standard blood pressure monitor.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.7 | ± 7.13 |
| Leu Sil 1.0mg | 1.8 | ± 9.57 |
| Leu Sil 4.0mg | -2.6 | ± 8.10 |
| Leu Met Sil 1.0mg | 1.1 | ± 9.16 |
| Leu Met Sil 4.0mg | -3.3 | ± 7.48 |
Change in Systolic blood pressure was assessed in patients from baseline to Day 168
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -2.0 | ± 9.97 |
| Leu Sil 1.0mg | 0.5 | ± 12.21 |
| Leu Sil 4.0mg | -2.7 | ± 9.12 |
| Leu Met Sil 1.0mg | 0.6 | ± 9.31 |
| Leu Met Sil 4.0mg | -3.5 | ± 9.29 |
Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Leu Sil 1.0mg | Leu Sil 4.0mg | Leu Met Sil 1.0mg | Leu Met Sil 4.0mg |
|---|---|---|---|---|---|---|
| Tooth abscess | Infections and infestations | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Anal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — |
| Reaction | System | Placebo | Leu Sil 1.0mg | Leu Sil 4.0mg | Leu Met Sil 1.0mg | Leu Met Sil 4.0mg |
|---|---|---|---|---|---|---|
| Diarrhoea | Renal and urinary disorders | — | — | — | — | — |
| Headache | General disorders | — | — | — | — | — |
| Nausea | General disorders | — | — | — | — | — |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Nasopharyngitis | General disorders | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Increased Appetite | General disorders | — | — | — | — | — |
| Sinusitis | General disorders | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| C-reactive protein increased | Blood and lymphatic system disorders | — | — | — | — | — |
| Constipation | Renal and urinary disorders | — | — | — | — | — |
| Hypertension | Blood and lymphatic system disorders | — | — | — | — | — |
| Influenza | General disorders | — | — | — | — | — |
| Pharyngitis | General disorders | — | — | — | — | — |
| Viral infection | General disorders | — | — | — | — | — |
Most-reported serious reactions: Tooth abscess, Hypokalaemia, Anal Cancer, Metastatic malignant melanoma.
Data from ClinicalTrials.gov NCT03364335 adverse events section.
This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24).
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03364335.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing