Safety, tolerability and efficacy of XEN-D0501 in adults with obesity

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What is this study about?

The study focuses on Obesity, a condition where excess body fat leads to health problems. It tests a new oral medication called XEN-D0501, supplied as a tablet, against a placebo. The trial is designed as a double-blind study, meaning neither the participants nor the researchers know which pill is active. The purpose of the study is to evaluate the safety and tolerability of increasing doses of XEN-D0501 compared with placebo in people with obesity.

Participants will be randomly assigned to receive either the active tablet or the placebo for a period of 12 weeks. During this time, regular visits will be scheduled to check weight, waist size, and basic blood tests, and to monitor heart rhythm using an ECG. Side effects, referred to as adverse events, will be recorded, and blood samples will be taken to study the drug’s pharmacokinetics, which describes how the medication is absorbed, distributed, and cleared from the body.

1 randomisation and receipt of study medication

after enrollment, you will be assigned by a computer program to receive either the investigational tablet xen‑d0501 or a matching placebo tablet. the assignment is unknown to you and to the study staff (double‑blind).

the study medication will be provided in bottles labeled with a code, and you will be instructed on how to store it.

2 start of dosing (day 1)

on the first day, you will begin taking one tablet by mouth each day. the exact amount of the tablet may be increased during the 12‑week period according to the study protocol.

the tablet should be swallowed with water and taken at the same time each day.

3 daily dosing for 12 weeks

you will continue to take the assigned tablet every day for a total of 12 weeks.

if the dose is increased, you will receive written instructions indicating the new amount and the date the change starts.

4 first follow‑up visit (week 4)

four weeks after starting the medication, you will attend a clinic visit.

during this visit, weight, waist and hip measurements, and basic laboratory tests (blood chemistry, blood pressure, pulse, temperature) will be performed.

the study team will ask about any side effects or health changes you have experienced.

5 second follow‑up visit (week 8)

eight weeks after the first dose, you will return for another clinic visit.

the same set of measurements and laboratory tests will be repeated, and any adverse events will be recorded.

if needed, the dose may be adjusted again based on safety and tolerability.

6 final visit and end of dosing (week 12)

at the end of the 12‑week period, you will attend the final study visit.

comprehensive assessments will be performed, including body weight, body composition, waist and hip circumference, blood lipid profile, fasting glucose, insulin, and hemoglobin a1c.

blood samples will also be taken to measure the level of xen‑d0501 in the plasma.

the study medication will be stopped, and you will be given instructions for any follow‑up care.

7 continuous safety monitoring

throughout the 12 weeks, you are asked to report any new symptoms, discomfort, or health problems to the study staff as soon as they occur.

serious or severe side effects will be evaluated promptly, and appropriate medical care will be provided.

Who Can Join the Study?

Be willing and able to sign a written form that shows you understand and agree to take part in the study (informed consent).
Be at least 25 years old when you sign the consent form.
Have a body mass index (BMI) between 30.0 and 39.9 kg/m². BMI is a number that compares your weight to your height to indicate obesity.
Have a stable weight for the past 3 months, meaning your body weight has not changed more than 5% up or down, based on your own report.
Have a blood test result called HbA1c that is less than 6.5% (or less than 48 mmol/mol). HbA1c shows your average blood sugar level over the previous 2‑3 months.
Follow the study’s birth‑control rules:
- If you are a woman who cannot become pregnant, you must either have had a hysterectomy, removal of both fallopian tubes, removal of both ovaries, or be post‑menopausal (no periods for 12 months or a blood test showing high follicle‑stimulating hormone).
- If you are a man, you must use a condom, be vasectomised, or practice sexual abstinence (only if this matches your usual lifestyle), avoid donating sperm from the first dose until 4 weeks after the last dose.
- If you are a man with a female partner who could become pregnant, your partner must use a highly effective birth‑control method (failure rate less than 1% per year) such as hormonal pills, hormonal injections or implants, an intrauterine device, or permanent sterilisation, starting at least 2 weeks before the first dose and continuing until 4 weeks after the last dose.

Who Cannot Join the Study?

Significant illness or disorder that the doctor thinks could put you at risk or affect the study results.
Any serious disease, medical procedure, or injury that happened within 4 weeks before the first dose.
Planned major surgery during the study period, including any planned weight‑loss surgery.
Having type 1 or type 2 diabetes.
Having a cancer diagnosis in the past 5 years, except for a very early skin cancer that was removed.
Heart problems such as a prolonged QTc interval (a measurement on an ECG over 450 ms), irregular heartbeats, or other important abnormalities on a resting heart test.
Untreated high blood pressure (systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg) at the screening visit.
Recent use (within 3 months) of medicines that lower blood sugar and also affect weight.
Current use of drugs that can change how the body handles glucose, such as systemic steroids or monoamine oxidase (MAO) inhibitors.
Recent or current intake of grapefruit or grapefruit‑containing products, or medicines that block the enzyme CYP3A4 (examples include ketoconazole, erythromycin, verapamil, fluconazole).
Use of any weight‑loss medicines or participation in a weight‑loss program within 90 days before screening.
Regular use of prescription or non‑prescription medicines within 2 weeks before the first dose, unless you are on a stable dose of antidepressants (such as SSRIs) for at least 2 months and the doctor allows it.
Known serious allergy to the study drug or any medicine that is chemically similar.
Positive test for hepatitis B surface antigen, hepatitis C antibodies, or HIV at screening.
Abnormal blood or chemistry test results that are considered clinically important by the doctor.
Low blood counts at screening: hemoglobin below 6.2 mmol/L (about 99.8 g/L), white blood cells below 3.0 × 10⁹/L, or platelets below 100 × 10⁹/L.
Poor kidney function, shown by an estimated glomerular filtration rate (eGFR) below 60 mL/min, or high serum creatinine (≥ 126 µmol/L for men, ≥ 111 µmol/L for women).
Liver test results that are too high: bilirubin more than 3 times the normal limit, ALT or AST more than 2 times the normal limit.
Elevated thyroid‑stimulating hormone (TSH) above the normal range.
Current smoking or use of nicotine products (occasional use less than three times a week is allowed).
Positive test for illegal or recreational drugs or alcohol at screening or before the first dose.
History of alcohol abuse or drinking too much, as judged by the doctor.
History of drug abuse, as judged by the doctor.
History of or current use of anabolic steroids (muscle‑building drugs).
Participation in another clinical trial with an investigational drug within the past 3 months.
Donation of whole blood or red blood cells, or losing more than 500 mL of blood, in the past 3 months, or planning to donate blood during the study.
Being pregnant, currently breastfeeding, or planning to become pregnant during the trial.
Having taken part in this same study before (previous randomisation).
If the doctor believes, based on your medical history or exam, that you have a much higher risk than other participants or that your condition or medicines could affect the study results.
Inability to understand the study or cooperate because of mental incapacity, language barriers, or unwillingness to take part.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
CTC Clinical Trial Consultants AB	Molndal	Sweden
CTC Clinical Trial Consultants AB	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	18.08.2026

Trial locations

XEN-D0501 is an experimental oral tablet being tested to see if it is safe and well‑tolerated in people who are obese. In this study, participants take the tablet for 12 weeks while researchers monitor how the body handles the drug, any side effects, and whether it helps with weight‑related outcomes. The medication is being compared to a placebo, but only the active drug is described here.

Investigated Diseases:

Obesity

Obesity – Obesity is a condition characterized by excess body fat that accumulates to a level that may affect health. It typically develops gradually as energy intake consistently exceeds energy expenditure over time. As body weight increases, fat stores expand and can lead to further weight gain if not addressed. The condition often progresses with increasing difficulty in losing weight due to metabolic and hormonal adaptations.

Trial ID:

2026-525869-42-00

Protocol code:

PP-CT04

Trial Phase:

Human Pharmacology (Phase I) – Other

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Safety, tolerability and efficacy of XEN-D0501 in adults with obesity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?