Phase 1 randomized, placebo-controlled study of ROSE-010 and paracetamol on appetite in overweight and obese adults

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What is this study about?

The study focuses on adults who have overweight or obesity. It evaluates a new medication called ROSE-010, which belongs to the class of drugs known as GLP-1 analogue. The medication is given as a subcutaneous injection and is compared with a saline solution that looks the same, referred to as a placebo.

The purpose of the study is to determine whether the test drug can reduce the amount of food eaten during a meal. Participants are randomly assigned to receive one of three treatments in a sequence, so each person will experience the test drug at two different dose levels and the placebo during separate visits, with sufficient time between visits to clear the previous dose.

During each visit, after the injection, participants stay at the clinic for several hours, then are offered a lunch where the quantity of food consumed is measured. They also rate feelings of hunger, fullness, and desire to eat using a simple line‑based questionnaire called a visual analogue scale. Safety is monitored through observation and routine lab checks, and any side effects are recorded.

1 randomisation and assignment to first treatment

after you join the study, a computer assigns you to receive one of three possible treatments for the first period: a low dose of ROSE-010, a higher dose of ROSE-010, or a placebo injection. the assignment is random and you will not know which you receive.

the study staff will explain the schedule for the first period and answer any questions you have.

2 first treatment period

baseline measurements are taken, including weight, vital signs, and initial appetite scores.

you receive a single subcutaneous injection. the injection contains either 150 µg of ROSE-010 or a clear saline solution that looks identical (placebo). the injection is given once for this period.

after the injection you proceed to an ad libitum lunch at the clinic. the amount of food you eat is measured for the study.

you complete a series of questionnaires using a visual analogue scale (a 0‑100 mm line) to rate hunger, satiety, desire to eat, prospective consumption, and nausea. these ratings are recorded at 1, 2, 3, 4, 5, and 6 hours after you start the lunch.

you are given paracetamol tablets (500 mg each). the total dose is 2 g, which equals four tablets taken orally as directed by the study staff. this medication is used as background treatment and may be taken during the observation period.

study staff monitor you for any adverse events, check laboratory safety parameters, and record any side effects that occur during the 6‑hour observation.

3 washout period after first treatment

a break period follows the first treatment to allow the medication to leave your body. no study medication is taken during this time. the length of the washout period is determined by the study protocol.

4 second treatment period

baseline measurements are repeated.

you receive a single subcutaneous injection of the next treatment assigned to you (the remaining dose of ROSE-010 or the placebo). the dose is again 150 µg if ROSE-010 is administered.

the same ad libitum lunch is offered, and the amount of food you eat is recorded.

you complete the same set of visual analogue scale questionnaires at 1‑6 hours after lunch.

you take the same total dose of paracetamol (2 g oral) as directed.

continuous safety monitoring and laboratory checks are performed as in the first period.

5 washout period after second treatment

another break period occurs to clear the previous medication from your system before the final treatment.

6 third treatment period

baseline assessments are carried out again.

you receive the remaining study injection (the last of the two ROSE-010 dose levels or the placebo) as a single subcutaneous injection of 150 µg if it is ROSE-010.

you attend the same ad libitum lunch and the food intake is measured.

you fill out the visual analogue scale questionnaires at 1, 2, 3, 4, 5, and 6 hours after lunch.

you take the prescribed total dose of 2 g paracetamol orally.

the study team continues to monitor for adverse events and conducts final laboratory safety checks.

7 study completion

after the third period, all study procedures are finished. the data collected from the three periods are used to compare the effects of the two ROSE-010 dose levels with the placebo on appetite and food intake.

you will be informed about any important findings that relate to your safety.

Who Can Join the Study?

Be willing and able to sign a written informed consent form and follow all study requirements.
Be a healthy man or woman between 30 and 65 years old at the time of signing the consent.
Have a Body Mass Index (BMI) of 27 to 32 kg/m², which is a calculation that compares weight to height.
If you are a woman who could become pregnant, you must agree to use an acceptable birth control method during the study, and you must have a negative pregnancy test (a urine test that looks for the hormone beta‑human chorionic gonadotropin) at screening and before each treatment period.
If you are a woman who cannot become pregnant, you must provide proof of either a tubal ligation (surgical closure of the fallopian tubes), a hysterectomy (removal of the uterus), or be post‑menopausal (no menstrual periods for 12 months, sometimes confirmed with a blood test for follicle stimulating hormone (FSH)).
If you are a man, you must be willing to use a condom, have had a vasectomy (surgical cut of the sperm ducts), or practice sexual abstinence (if that is your usual lifestyle) to prevent pregnancy and drug exposure to a partner, and you must not donate sperm from the day of dosing until three months after the last dose.
Have no significant problems found during the physical exam, vital signs check, electrocardiogram (ECG) (a test that records heart activity), or laboratory tests at the screening visit, as judged by the study doctor.

Who Cannot Join the Study?

Having a past or current disease that the doctor thinks could put you at risk or affect the study results.
Blood pressure or heart rate outside normal limits after lying down for 10 minutes: systolic (top number) less than 100 or greater than 140 mmHg, diastolic (bottom number) less than 50 or greater than 90 mmHg, or pulse (beats per minute) less than 45 or greater than 90.
Severe allergy or hypersensitivity, especially to medicines similar to the study drug or its ingredients.
Regular use of any prescription or over‑the‑counter medication, including antacids, proton pump inhibitors (medicines that reduce stomach acid), pain relievers, herbal products, vitamins or minerals, within two weeks before the first study visit.
Planning to take or having taken another investigational drug within three months before the first study visit.
Being a regular smoker or using nicotine products; only very occasional use (less than three times a week) is allowed.
History of alcohol abuse or drinking excessively, as judged by the doctor.
Current or past drug abuse, as judged by the doctor.
Testing positive for illegal drugs or alcohol at screening or before any study day.
History of, or current use of, anabolic steroids (muscle‑building hormones).
Inability to avoid caffeine‑containing drinks (such as coffee, tea, cola) during the study days because you would get headaches or other problems.
Gastrointestinal problems such as IBS (irritable bowel syndrome), previous major stomach or intestine surgery, or any condition that changes acid reflux or how quickly the stomach empties.
Donating plasma within one month of screening or donating blood (or losing a similar amount of blood) within three months before screening.
If the doctor believes you are unlikely to follow the study procedures, restrictions, or requirements.
Previous anti‑reflux surgery or abdominal surgery, except for removal of the appendix.
History of pancreatitis (inflammation of the pancreas) or a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (hereditary hormone‑related tumors).
Any serious illness, medical or surgical procedure, or injury that occurred within four weeks before the first study visit.
Cancer diagnosed within the past five years, except for certain skin cancers (basal cell or squamous cell) that were removed and have not spread for at least three years.
Unstable weight, meaning your weight changed by 5 % or more in the three months before screening.
Being pregnant, breastfeeding, planning to become pregnant during the study, or having given birth within the past six months.
Planning to have major surgery during the time you would be in the study.
Testing positive for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Cxs Caisfpji Twpyk Ceixcxcnpgu Am	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.11.2023

Trial locations

Investigated Drugs:

Paracetamol

Alvedon is a medication that contains the active ingredient paracetamol. It is taken by mouth and is commonly used to relieve mild pain and reduce fever. In this study, every participant receives Alvedon as a background treatment so that any pain or fever that might occur during the trial is managed consistently across all groups.

ROSE-010 is an experimental drug that belongs to a class called GLP‑1 analogues. It is given as a small injection under the skin. The purpose of ROSE‑010 in this trial is to see whether it can lower appetite and reduce the amount of food that people eat when they are allowed to choose freely. Researchers are testing its safety and early signs of effectiveness in overweight and obese volunteers.

Investigated Diseases:

Overweight – A condition in which a person’s body weight is higher than what is considered normal for their height, usually defined by a body‑mass index (BMI) of 25–29.9. It often develops slowly when more calories are taken in than are used, especially with a sedentary lifestyle. Over time the excess weight may increase, moving the individual toward obesity if the pattern continues. The extra weight can affect how the body handles food and may increase feelings of hunger. The condition can remain stable or gradually worsen depending on lifestyle changes.
Obesity – A condition characterized by excessive body fat, typically defined by a BMI of 30 or higher. It usually develops over many years as calorie intake consistently exceeds energy expenditure. Fat accumulates in various parts of the body, and weight often continues to rise if habits do not change. This excess fat can alter the body’s metabolism and appetite signals. If weight gain persists, the condition can progress to more severe levels of obesity.

Trial ID:

2023-507758-34-00

Protocol code:

RP-23-01

Trial Phase:

Human Pharmacology (Phase I) – Other

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Phase 1 randomized, placebo-controlled study of ROSE-010 and paracetamol on appetite in overweight and obese adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?