AzTrials
AzTrials

Overweight or ObesityPhase 1NCT06013163

A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers

A Phase 1 study testing Xenical® vs EMP 22, EMP 22 vs Xenical® and EMP 16 vs Xenical® in people with Overweight or Obesity, run by Empros Pharma AB at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but lacks the acarbose component. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Overweight or Obesity
What is being tested?
Xenical® vs EMP 22, EMP 22 vs Xenical® and EMP 16 vs Xenical®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSweden
Study dates
22 Sep 2023to Dec 2024
Phase
Phase 1
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 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Willing and able to give written informed consent for participation in the trial.
  • Healthy male or female aged 20 to 55 years inclusive.
  • Participants with a BMI between 20 and 27 kg/m² or participants with a BMI >27 kg/m2 and normal body fat composition (10 to 25% for men and 20 to 30% for women measured using a bioimpedance scale) at screening.
  • Weight stable (<5% self-reported change during the previous 3 months preceding screening).
  • Participants with a self-perceived normality in defecation habits, normally with a stool frequency of at least once daily.
  • Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, electrocardiogram (ECG) and laboratory values at the time of the screening visit, as judged by the Investigator.

Who cannot join

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial including but not limited to:
  • GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowel syndrome (IBS).
  • Cholestasis.
  • Previous GI surgery that might influence GI function significantly, such as previous bariatric surgery, and previous gallbladder surgery as judged by the investigator.
  • Vitamin B12 deficiency or other signs of achlorhydria.
  • Chronical malabsorption syndrome.
Show all 24Show fewer
  • History of severe allergic, cardiac or hepatic disease.
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
  • Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
  • Any planned major surgery within the duration of the trial.
  • Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
  • Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
  • Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class as orlistat or acarbose.
  • Regular use of any prescribed or non-prescribed medications (including, but not limited to, antacids, analgesics, herbal remedies, vitamins and minerals) within 2 weeks prior to the first administration of IMP except as outlined in Section 9.6.2.3.
  • Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within 3 months of the first administration of IMP in this trial. Subjects consented and screened but not dosed in previous studies are not excluded.
  • Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week is allowed before the screening visit.
  • Positive screening result for drugs of abuse or alcohol at the screening visit.
  • History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
  • Presence or history of drug abuse, as judged by the Investigator.
  • History of, or current use of anabolic steroids, as judged by the Investigator.
  • Excessive caffeine consumption defined by a daily intake of > 5 cups (1 cup = approximately 240 mL) of caffeine containing beverages, as judged by the Investigator.
  • Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
  • The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country.

Ulf Holmbäck, PhD contact

+4670 173 00 41

ulf.holmback@emprospharma.com

Ulf Holmbäck contact

+4670 173 00 41

ulf.holmback@emprospharma.com

Sweden1 site, 1 recruiting

  • CTC Clinical Trial Consultanta AB

    Uppsala, 752 37

    Helena Litorp, MD, PhD, +46 (0)72 225 00 75, helena.litorp@ctc-ab.se

    Helena Litorp, MD, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: Control Of BioEquivalence With Xenical (COBEX): A Phase I, Randomised, Active-control Study to Evaluate EMP22 Pharmacodynamics and EMP16 Pharmacokinetics Versus Xenical® in Healthy Volunteers

This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but lacks the acarbose component. Part II will explore the PK properties of EMP16 alone and vs. Xenical®. Part I will be conducted in a single-blind, cross-over fashion while Part II will have an open-label, fixed-sequence design. Healthy volunteers will be recruited to the trial.

Read the detailed description

Approximately 35 participants are planned to be screened to achieve 20 randomised participants and at least 16 evaluable participants in Part I.

All participants who complete Part I will continue in Part II.

Each participant is expected to participate in the trial for approximately 9 to 13 weeks (depending on the length of each wash-out period), including a 28-day screening period.

Part I: Participants will self-administer EMP22 for 9 days and Xenical® for 9 days (TID dosing) at home. EMP22 and Xenical® should be taken halfway through each of the 3 main meals during the day (breakfast, lunch, dinner) with approximately 50 to 200 mL water.

EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind for the participants, the IMP will be administered as follows:

  • EMP22 60 mg orlistat, 2 capsules TID.
  • Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID.

Part II: Following an overnight fast of at least 8 hours and a light standardised breakfast upon admission (approximately 2 hours prior to dose), EMP16 will be taken halfway through a regular standardised breakfast (5 minutes after the start of the meal, which is expected to be finished in 10 minutes) with approximately 50 to 200 mL water. After a 4-14 day washout, the same procedure will be repeated using Xenical® .

The participants will receive a single dose dose of EMP16 (2 capsules, each of 60 mg) and a single dose of Xenical® (1 capsule, 120 mg).

Being tested
Xenical® vs EMP 22, EMP 22 vs Xenical®, EMP 16 vs Xenical®
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.

  • Xenical® vs EMP 22Drug

    Also called Part I

    Each participant will first use Xenical® TID for 9 days and then EMP22TID for 9 days (in total 27 doses of each drug).

  • EMP 22 vs Xenical®Drug

    Also called Part I

    Each participant will first use EMP22 TID for 9 days and then Xenical® TID for 9 days (in total 27 doses of each drug).

  • EMP 16 vs Xenical®Drug

    Also called Part II

    Each participant will receive a single dose of EMP16 and then a single dose of Xenical®.

Study groups in NCT06013163
Study groupRoleWhat they receive
Xenical - EMP22 part 1 crossover blindedActive comparatorAfter a 5-day diet run-in period, orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; EMP22 (120 mg modified release orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.
Receives: Drug: Xenical® vs EMP 22
EMP22 - Xenical part 1 crossover blindedActive comparatorAfter a 5-day diet run-in period, EMP22 (120 mg modified release orlistat) will be taken 3 times daily (ter in die [TID]) together with the 3 main daily meals for a 9-day treatment period. After a 4-to-14-day wash-out period; orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken TID together with the 3 main daily meals for a 9-day treatment period.
Receives: Drug: EMP 22 vs Xenical®
EMP16 - Xenical part 2 sequential open labelActive comparatorSingle dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day. After a 4-to-14-day wash-out period, Xenical® (120 mg orlistat) will be taken together with breakfast during one PK study day.
Receives: Drug: EMP 16 vs Xenical®

What is being measured

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

  1. The percent of faecal fat

    The percent of faecal fat excretion expressed as a ratio of the amount of fat excretion over a 24-hour period at steady-state relative to the amount of daily ingested fat.

    Measured: Day -2 , Day -1 , and between the morning of Day 9 and Day 10.

Secondary outcomes (6)

  1. Cmax - to explore the PK properties of EMP16

    Cmax for orlistat and acarbose

    Measured: 12 hour for each day of treatment

  2. Tmax - to explore the PK properties of EMP16

    Tmax for orlistat and acarbose

    Measured: 12 hour for each day of treatment

  3. AUC0-t - to explore the PK properties of EMP16

    AUC0-t for orlistat and acarbose

    Measured: 12 hour for each day of treatment

  4. Cmax - to compare the bioavailability of orlistat in EMP16 and Xenical®

    Cmax for orlistat

    Measured: 12 hour for each day of treatment

  5. Tmax - to compare the bioavailability of orlistat in EMP16 and Xenical®

    Tmax for orlistat

    Measured: 12 hour for each day of treatment

  6. AUC0-t - to compare the bioavailability of orlistat in EMP16 and Xenical®

    AUC0-t for orlistat

    Measured: 12 hour for each day of treatment

Timeline

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

  1. First posted28 Aug 2023
  2. Study start22 Sep 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
In Part I (single-blind), EMP22 (120 mg orlistat) and orlistat in its conventional form (Xenical®, 120 mg orlistat) will be taken 3 times daily (ter in die \[TID\]) together with the 3 main daily meals for two 9-day treatment periods in a cross-over manner. In Part II (open-label), single doses of EMP16 (120 mg orlistat/40 mg acarbose) and Xenical® (120 mg orlistat) will be taken together with breakfast on 2 separate days.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06013163
Sponsor's protocol ID
EP-004
Other IDs
2023-505671-74-00, 2023
Status last verified
Oct 2023
First submitted
22 Aug 2023
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xenical® vs EMP 22, EMP 22 vs Xenical® and EMP 16 vs Xenical® in people with Overweight or Obesity, run by Empros Pharma AB at 1 site 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 24 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Ulf Holmbäck, PhD (+4670 173 00 41, ulf.holmback@emprospharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percent of faecal fat (time frame: Day -2 , Day -1 , and between the morning of Day 9 and Day 10.). 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 NCT06013163.

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 4 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in