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Overweight or ObesityPhase 2NCT05934110

Study Exploring the Supportive Effect of Acarbose in Weight Management

A Phase 2 study testing EMP16-120/40, MR orlistat 120 mg and Conventional orlistat 120 mg, in people with Overweight or Obesity, run by Empros Pharma AB at 3 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, double-blind study in participants with overweight or obesity in which the effect of acarbose and the impact of dose on efficacy, safety and tolerability is investigated by comparing the EMP16 combination product with modified release (MR) orlistat, orlistat in its conventional dosage form and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight or Obesity
What is being tested?
EMP16-120/40, MR orlistat 120 mg and Conventional orlistat 120 mg,
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
3 sitesSweden
Study dates
18 Apr 2023to 15 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to give written informed consent for participation in the study.
  • Males or females (sex distribution 50:50, preferably ±5%) aged ≥18 years.
  • BMI ≥ 30 or ≥ 27 kg/m² in the presence of other risk factors based on participant interview e.g., hypertension (either or not treated with antihypertensive agents), glucose dysregulation (defined as elevated fasting glucose ≥6.1 mmol/L or HbA1c >42mmol/mol), Type 2 Ddabetes that is treated with lifestyle changes (no medication allowed), and/or dyslipidemia (either or not treated with antihyperlipidemic agents). If indicated, plasma/serum total cholesterol, LDL, HDL, and/or TGs can be measured to verify eligibility as judged by the Investigator.
  • No clinically significant abnormalities regarding physical examination, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
  • Adequate renal function: creatinine <1.5 times upper limit of normal (ULN).
  • Adequate hepatic function: aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase <2.5 times upper level of normal (ULN) and bilirubin <1.5 times ULN.

Who cannot join

  • Weight unstable (≥ 5% reported change during the previous 3 months) preceding screening and randomization.
  • Subjects who are pregnant, who are currently breastfeeding, who intend to become pregnant within the period of the study, or who gave birth within the 6 months preceding the screening visit.
  • Type 2 diabetes treated with medication.
  • History or presence of any clinically significant disease, disorder, or history of surgery which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study including but not limited to:
  • GI problems/diseases, e.g., diseases that affect intestinal absorption and peristalsis such as inflammatory bowel diseases, irritable bowel syndrome (IBS) and Hirschsprung's disease
  • Cholestasis
Show all 25Show fewer
  • Chronical malabsorption syndrome
  • Severe allergic, cardiac, or hepatic disease
  • Previous GI surgery that might influence GI function significantly, such as previous bariatric surgery, and previous gallbladder surgery as judged by the investigator.
  • Potential participants with well-treated chronic diseases (e.g., celiac disease and lactose intolerance) may be included in the study at the discretion of the Investigator.
  • Significant clinical illness within the preceding 2 weeks of the first administration of IMP at the discretion of the Investigator.
  • Any significant medical/surgical procedure or trauma within 4 weeks of the first administration of IMP at the discretion of the Investigator.
  • Any planned major surgery within the duration of the study.
  • Any use of drugs altering glucose metabolism and drugs used for diabetes (A10A and A10B) or drugs that are affected by, or that affect, orlistat and acarbose, within 2 weeks prior to the first administration of IMP.
  • Regular use of prescribed or non-prescribed medication within 2 weeks prior to the first administration of IMP as judged by the Investigator. Patients who are on stable treatment with anti-depressants (e.g., selective serotonin re-uptake inhibitors, SSRI) for at least 2 months can be included at the discretion of the Investigator.
  • Untreated high blood pressure (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at the screening visit).
  • Known hypersensitivity to any of the test substances.
  • Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
  • Excessive intake of alcohol, as judged by the Investigator.
  • Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
  • Positive screen for drugs of abuse, or positive screen for alcohol, at the screening visit (Visit 1).
  • Any positive result at the screening visit (Visit 1) for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
  • Plasma donation within 1 month of the screening visit (Visit 1) or any blood donation (or corresponding blood loss) during the 3 months prior to the screening visit.
  • Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of IMP in this study. Participants consented and screened but not dosed in previous studies are not excluded.
  • Investigator considers the potential participant unlikely to comply with study procedures, restrictions, and requirements.

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • CTC Ebbepark

    Linköping, SE-582 13

  • CTC Karolinska

    Solna, SE-171 64

  • Clinical Trial Consultants (CTC)

    Uppsala, SE-752 37

Other trials in Sweden

About this study

Official title: A 26-week, Double-blind, Randomized Study in Participants With Overweight or Obesity Investigating the Added Contribution of Acarbose in EMP16 on Efficacy, Safety and Tolerability

This is a randomized, double-blind study in participants with overweight or obesity in which the effect of acarbose and the impact of dose on efficacy, safety and tolerability is investigated by comparing the EMP16 combination product with modified release (MR) orlistat, orlistat in its conventional dosage form and placebo.

Read the detailed description

The study will be conducted at 3 research sites in Sweden. A total of 320 randomized patients are expected to participate in the study for approximately 31 weeks, including a screening period of up to 5 weeks and a 26-weeks treatment period.

EMP16 is indicated for people with obesity with an initial BMI ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of other risk factors (e.g., hypertension, glucose dysregulation and T2DM, and/or dyslipidemia).

Participants will be randomized to either of 5 arms:

  • EMP16-120/40, 80 participants
  • MR orlistat 120 mg, 80 participants
  • Conventional orlistat 120 mg, 80 participants
  • EMP16-60/20, 40 participants
  • Placebo, 40 participants
Being tested
EMP16-120/40, MR orlistat 120 mg, Conventional orlistat 120 mg,, EMP16-60/20, Placebo
Keywords
Overweight, Obesity
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMP16-120/40Drug

    EMP16 is supplied as oral MR capsules with the strength of 60 mg orlistat/20 mg acarbose.

    Dosage:

    week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose (2 capsules TID).

  • MR orlistat 120 mgDrug

    MR orlistat 120 mg is the same as EMP16-120/40 but without the acarbose component in matching oral capsules.

    Dosage:. week 1-2: 60 mg MR orlistat (1 capsule per day), week 3-4: 60 mg MR orlistat (1 capsule TID), week 5-26: 60 mg MR orlistat (2 capsules TID).

  • Conventional orlistat 120 mg,Drug

    Also called Xenical

    Orlistat in its conventional form will be Alli® 60 mg during week 1 to 4 and Xenical® 120 mg from week 5 and onwards in matching oral capsules.

    Dosage:

    week 1-2: 60 mg conventional orlistat (1 capsule per day), week 3-4: 60 mg conventional orlistat (1 capsule TID), week 5-26: 120 mg conventional orlistat plus placebo (1 capsule of each TID).

  • EMP16-60/20Drug

    Dosage:

    week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)

  • PlaceboDrug

    Dosage:

    week 1-2: Placebo (1 capsule per day), week 3-4: Placebo (1 capsule TID), week 5-26: Placebo (2 capsules TID)

Study groups in NCT05934110
Study groupRoleWhat they receive
EMP16-120/40ExperimentalEMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40), 80 participants.
Receives: Drug: EMP16-120/40
MR orlistatActive comparatorMR orlistat 120 mg, 80 participants.
Receives: Drug: MR orlistat 120 mg
Conventional orlistatActive comparatorConventional orlistat 120 mg, 80 participants.
Receives: Drug: Conventional orlistat 120 mg,; Drug: Placebo
EMP16-60/20ExperimentalEMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20), 40 participants.
Receives: Drug: EMP16-60/20; Drug: Placebo
PlaceboPlacebo comparatorPlacebo, 40 participants
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative (%) change from baseline in body weight at week 26

    Efficacy endpoints

    Measured: Baseline and week 26

  2. Proportion of participants with ≥5% decrease in body weight at week 26 [Please note: This is an FDA required outcome, cannot use "change"]

    Efficacy endpoints

    Measured: Baseline and week 26

Secondary outcomes (33)

  1. Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons)

    Efficacy endpoints

    Measured: Baseline and week 26

  2. Proportion of participants with ≥5% (secondary and exploratory comparisons) and ≥10% (all comparisons) decrease in body weight at week 18 and week 26

    Efficacy endpoints

    Measured: Baseline, week 18 and 26

  3. Absolute change from baseline in body weight at week 26

    Efficacy endpoints

    Measured: Baseline and week 26

  4. Relative (%) change from baseline in body weight during the 26-weeks treatment period

    Efficacy endpoints

    Measured: Baseline to week 26

  5. Absolute change from baseline in body weight during the 26-weeks treatment period

    Efficacy endpoints

    Measured: Baseline to week 26

  6. Absolute change from baseline in body mass index (BMI) measured as weight (kg) divided by height (m) squared

    Efficacy endpoints

    Measured: Baseline and week 26

  7. Absolute change from baseline in waist circumference

    Efficacy endpoints

    Measured: Baseline and week 26

  8. Absolute change from baseline in sagittal diameter

    Efficacy endpoints

    Measured: Baseline and week 26

  9. Absolute change from baseline in percentage body fat

    Efficacy endpoints

    Measured: Baseline and week 26

  10. Absolute change from baseline in Quality of life as measured by the questionnaire Rand-36 (9 different domains)

    Efficacy endpoints

    Measured: Baseline and week 26

  11. Absolute change from baseline in Quality of life as measured by the questionnaire EQ-5D-5L (measured as one summative value)

    Efficacy endpoints

    Measured: Baseline and week 26

  12. Absolute change from baseline in self reported meal pattern. Short questionnaire where points are depending on adherence to the Nordic Nutrition recommendations

    Efficacy endpoints.

    Measured: Baseline and week 26

  13. Absolute change from baseline in self reported sleep, where higher points are given for good sleep duration and good sleep quality

    Efficacy endpoints

    Measured: Baseline and week 26

  14. Absolute change from baseline in self reported physical activity, where higher points are given for longer duration of moderate and intense physical activity

    Efficacy endpoints

    Measured: Baseline and week 26

  15. Absolute change from baseline in fasting hemoglobin A1c (HbA1c)

    Efficacy endpoints

    Measured: Baseline and week 26

  16. Absolute change from baseline in fasting glucose

    Efficacy endpoints

    Measured: Baseline and week 26

  17. Absolute change from baseline in fasting insulin

    Efficacy endpoints

    Measured: Baseline and week 26

  18. Absolute change from baseline in fasting total cholesterol

    Efficacy endpoints

    Measured: Baseline and week 26

  19. Absolute change from baseline in fasting high-density lipoprotein (HDL)

    Efficacy endpoints

    Measured: Baseline and week 26

  20. Absolute change from baseline in fasting low-density lipoprotein (LDL)

    Efficacy endpoints

    Measured: Baseline and week 26

  21. Absolute change from baseline in fasting triglycerides (TGs)

    Efficacy endpoints

    Measured: Baseline and week 26

  22. Absolute change from baseline in fasting Apolipoprotein A1 (ApoA1)

    Efficacy endpoints

    Measured: Baseline and week 26

  23. Absolute change from baseline in fasting Apolipoprotein B (ApoB)

    Efficacy endpoints

    Measured: Baseline and week 26

  24. Absolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP)

    Efficacy endpoints

    Measured: Baseline and week 26

  25. Absolute change from baseline in fasting albumin

    Efficacy endpoints

    Measured: Baseline and week 26

  26. Absolute change from baseline in homeostatic model assessment (HOMA) index

    Efficacy endpoints

    Measured: Baseline and week 26

  27. Absolute change from baseline in Visceral adiposity index (VAI)

    Efficacy endpoints VAI Males = (WC/(39.38+(1.88*BMI)))*(TG/1.03)*(1.31/HDL) VAI Females = (WC/(36.58+(1.89*BMI)))*(TG/0.81)*(1.52/HDL)

    Measured: Baseline and week 26

  28. Absolute change from baseline in Fatty liver index (FLI)

    Efficacy endpoints. Measured as FLI = 100*e to the power of y /(1+e to the power of y) y= 0.953*ln(TG)+0,139*BMI+0.718*ln(GGT)+0.053*WC-15.3745

    Measured: Baseline and week 26

  29. Absolute change from baseline in systolic and diastolic blood pressure

    Efficacy endpoints

    Measured: Baseline and week 26

  30. Absolute change from baseline in heart rate

    Efficacy endpoints

    Measured: Baseline and week 26

  31. Tolerability, assessed by conventional adverse event (AE) reporting (with special focus on oily spotting and fecal incontinence)

    Safety \& tolerability endpoints

    Measured: IMP administration until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits)

  32. Number of withdrawals from study (total and gastrointestinal [GI] related)

    Safety \& tolerability endpoints

    Measured: Visit 1 until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits)

  33. Absolute change from baseline in fasting liver enzymes

    Safety \& tolerability endpoints (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and gamma-glutamyl transferase)

    Measured: Baseline and week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start18 Apr 2023
  3. Primary completion21 Nov 2023
  4. Study completion15 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, double-blind study in participants with overweight or obesity in which the effect of acarbose and the impact of dose on efficacy, safety and tolerability is investigated by comparing the EMP16 combination product with modified release (MR) orlistat, orlistat in its conventional dosage form and placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934110
Sponsor's protocol ID
EP-003
Other IDs
2022-003320-40
Status last verified
Feb 2024
First submitted
29 May 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EMP16-120/40, MR orlistat 120 mg and Conventional orlistat 120 mg, in people with Overweight or Obesity, run by Empros Pharma AB at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative (%) change from baseline in body weight at week 26 (time frame: Baseline and week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05934110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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