Trial · NCT04521751
A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary)
NCT04521751, Phase 1, Phase 2, Completed, Empros Pharma AB
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary). Trials, record NCT04521751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04521751
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary)
- NCT number
- NCT04521751
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 156 participants, actual
- Lead sponsor
- Empros Pharma AB
- Conditions
- Overweight or Obesity
- Interventions
- EMP16-02 120 mg orlistat/40 mg acarbose, EMP16-02 150 mg orlistat/50 mg acarbose, Placebo
- First posted
- 2020-08-21
- Last updated
- 2022-04-04
Source ClinicalTrials.gov
Registered outcomes59
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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/NCT04521751
GET https://conductscience.org/api/trials/v1/NCT04521751/registered?page=2