Registered outcomes59

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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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List	Outcome	Time frame	Description
Secondary	Alkaline phosphatase (ALP): 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 alkaline phosphatase (ALP) 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	Gamma-glutamyl transferase (GGT): 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 gamma-glutamyl transferase (GGT) 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	Proportion of diabetic (fasting glucose ≥ 7.0 mmol/L) and prediabetic patients (fasting glucose ≥ 6.1 mmol/L and < 7.0 mmol/L) 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.	Change from baseline in the proportion of diabetic (fasting glucose ≥ 7.0 mmol/L) and prediabetic patients (fasting glucose ≥ 6.1 mmol/L and \< 7.0 mmol/L) 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	Blood pressure, 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 blood pressure 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	Health and life quality questionnaire (RAND-36), 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 and week 26.	Change from baseline in quality of life after 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. The questionnaire is owned by RAND Corporation USA and translated to swedish by Registercentrum SydOst (RCSO). The health and quality of life questionnaire consists of 36 questions about how the patient experiences his/her own physical and mental health.
Secondary	Activity and sleep questionnaire, 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.	Change from baseline in activity and sleep after 26 weeks of treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo. The questionnaire is generated by Empros Pharma. The activity and sleep questionnaire consists of 2 questions about physical activity and sleep during the previous day/night.
Secondary	Drop-out rate (overall and GI-related), for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A)	From first dose until the date of drop-out, assessed up to 26 weeks.	Dropout rate (overall and GI-related) following treatment with EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo.
Secondary	Frequency and severity of AEs, for EMP16-02 (120 mg O/40 mg A and 150 mg O/50 mg A)	From first dose until date of resolution of last AE registered or to End of study visit (week 28), whichever comes first.	Frequency and severity of AEs during 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	Bilirubin (total), clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in bilirubin (total) after 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	Bilirubin (conjugated), clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in bilirubin (conjugated) after 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	Calcium, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in calcium after 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	Creatinine, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in creatinine after 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	Phosphate, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in phosphate after 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	Potassium, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in potassium after 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	Sodium, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in sodium after 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	Urea, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in urea after 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	Haematocrit, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in haematocrit after 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	Haemoglobin (Hb), clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in haemoglobin (Hb) after 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	Platelet count, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in platelet count after 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	Red blood cell (RBC) count, clinically significant relative (%) and absolute changes 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 and week 26.	Clinically significant relative (%) and absolute changes from baseline in Red blood cell (RBC) count after 26 weeks of treatment with EMP16 02 (120 mg O/40 mg A and 150 mg O/50 mg A) as compared to placebo.