Trial · NCT04521751
Registered outcomes59
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 59
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Body weight, relative (%) change from baseline for EMP16-02 (120 mg O/40 mg A) | From first dose to last dose (week 26). Measured at baseline and week 26. | Relative (%) change from baseline in body weight after 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A) as compared to placebo. |
| Secondary | Body weight, absolute change from baseline for EMP16-02 (120 mg O/40 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Absolute change from baseline in body weight after 14 and 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A) as compared to placebo. |
| Secondary | Body weight, relative (%) and absolute change from baseline for EMP16-02 (150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Relative (%) and absolute change from baseline in body weight after 14 and 26 weeks of treatment with EMP16-02 (150 mg O/50 mg A) as compared to placebo. |
| Secondary | Proportion of patients with ≥5% and ≥10% decrease in body weight for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Proportion of patients with ≥5% and ≥10% decrease in body weight compared to baseline after 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | BMI, relative (%) and absolute change from baseline for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Relative (%) and absolute change from baseline in BMI after 14 and 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Waist circumference, absolute change from baseline for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Absolute change from baseline in waist circumference after 14 and 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Sagittal diameter, absolute change from baseline for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Absolute change from baseline in sagittal diameter after 14 and 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Percentage body fat, relative (%) and absolute change from baseline for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 14 and week 26. | Relative (%) and absolute change from baseline in percentage body fat after 14 and 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Questionnaire Satiety and craving, after 14 and 26 weeks for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Questionnaire Satiety and craving (generated by Empros Pharma AB) after 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo, corrected for satiety and craving after standardised breakfast at baseline. The questionnaire is generated by Empros Pharma and consists of 7 questions about sense of hunger, sense of satiety and cravings for certain types of food that needs to be answered on a scale from 0 (not at all) to 9 (extremely much). |
| Secondary | Haemoglobin A1C (HbA1c): Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting haemoglobin A1C (HbA1c) after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Glucose: Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting glucose after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Insulin: Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting insulin after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Total cholesterol: Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting total cholesterol after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | High-density lipoprotein (HDL): Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting high-density lipoprotein (HDL) after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Low-density lipoprotein (LDL): Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting low-density lipoprotein (LDL) after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Triglycerides: Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting triglycerides after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Albumin: Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting albumin after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | High-sensitivity C-reactive protein (hs CRP): Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting high-sensitivity C-reactive protein (hs CRP) after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Alanine aminotransferase (ALT): Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting alanine aminotransferase (ALT) after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
| Secondary | Aspartate aminotransferase (AST): Relative (%) and absolute change from baseline for EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) | From first dose to last dose (week 26). Measured at baseline, week 7, week 14, and week 26. | Relative (%) and absolute change from baseline in fasting aspartate aminotransferase (AST) after 7, 14 and 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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