A randomised, placebo-controlled, double-blinded, cross-over, Phase 1 study evaluating the safety and preliminary efficacy of the GLP 1 analogue ROSE-010 on appetite and food intake in overweight and obese subjects.

Trial details

Who runs it

Rose Pharma Inc.

Trial code

EU 2023-507758-34-00

Record updated

2023. november 9.

Original description

To assess the efficacy of ROSE-010 on ad-libitum food intake.Read full original descriptionShow less

To assess the efficacy of ROSE-010 on ad-libitum food intake.

This will be a randomised, placebo-controlled, double-blinded, three-treatment, three-period cross-over study.

Inclusion: Willing and able to give written informed consent for participation in the study and to comply with study requirements; Healthy male or female subject aged 30-65 years (inclusive) at the time of signing the informed consent; BMI ≥ 27 and ≤ 32 kg/m2 ; Women of child-bearing potential (WOCBP) (for definition see Section 9.3.7.1): Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.3.7.1). A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at screening and Day -1 of each treatment period will be required. Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal (defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) 25-140 IE/L is confirmatory]). Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence (only allowed when this is the preferred and usual lifestyle of the subject) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see Section 9.3.7.1); 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.

Exclusion: Regular use of any prescribed or non-prescribed medication including antacids, proton pump inhibitors (PPIs), analgesics, herbal remedies, vitamins, and minerals within 2 weeks prior to Day 1 (Visit 2), at the discretion of the Investigator; Planned treatment or treatment with another investigational drug within 3 months prior to Day 1 (Visit 2). Subjects consented and screened but not dosed in previous Phase 1 studies are not excluded; Positive screen for drugs of abuse or alcohol at screening or Day -1 (Visit 2, Visit 3 and Visit 4), prior to administration of the IMP; Gastrointestinal conditions such as IBS, previous major gastrointestinal surgery or any condition affecting gastric oesophageal reflux and gastric emptying that may affect study interpretation, in the judgement of the Investigator; Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening; Previous antireflux surgery or abdominal surgery, except appendectomy; Weight unstable (≥ ± 5% reported change during the previous 3 months) preceding screening and randomisation; Any planned major surgery within the duration of the study; History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study; 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 to the IMPs and/or auxiliary medicinal product (AxMP), including any of the excipients; 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; History of pancreatitis, history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia; Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of Day 1 (Visit 2); Malignancy within the past 5 years, with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV); After 10 min supine rest at the time of screening, any vital signs values outside the following ranges: Systolic blood pressure <100 or >140 mmHg, or Diastolic blood pressure <50 or >90 mmHg, or Pulse <45 or >90 beats per minute (bpm); Current regular smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before Day -1 (Visit 2); Inability to refrain from consuming caffeine-containing beverages during Day 1 (Visit 2, Visit 3 and Visit 4), e.g. propensity to develop headaches when refraining from caffeine-containing beverages; Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements; 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.

EU CTIS 2023-507758-34-00