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Weight management with orismilast alone or in combination with s.c. semaglutide (WELOSITI)
EU CTIS ID: 2024-517463-23-00
What this study is testing
This randomised placebo-controlled study will investigate the efficacy of orismilast administered orally twice daily (BID) separately or combined with open-label once weekly s.c. administered semaglutide in individuals with obesity during a 16-week treatment period. The primary aim is to evaluate the effects of 30 mg orismilast BID with- or without semaglutide 1.0 mg s.c. once weekly on percentual change from baseline in body weight.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-75
- BMI ≥ 30 kg/m²
- History of at least one attempt to lose body weight
You likely can't join if
- A self-reported change in body weight ≥ 5% within the last three months prior to the screening visit
- History of major depressive disorder within 2 years of screening
- Unstable severe psychiatric disorder (e.g. bipolar disorder or schizophrenia)
- Suicidal behaviour three months prior to screening visit
- Any prior suicidal attempt
- Class IV heart failure, according to the New York Heart Association
See the full eligibility criteria
- Age 18-75
- BMI ≥ 30 kg/m²
- History of at least one attempt to lose body weight
- A self-reported change in body weight ≥ 5% within the last three months prior to the screening visit
- History of major depressive disorder within 2 years of screening
- Unstable severe psychiatric disorder (e.g. bipolar disorder or schizophrenia)
- Suicidal behaviour three months prior to screening visit
- Any prior suicidal attempt
- Class IV heart failure, according to the New York Heart Association
- Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardise the participant’s safety during the trial
- Alcohol/drug abuse as per discretion of the investigators
- Known or suspected hypersensitivity to orismilast, semaglutide or related products
- Administration of any investigational drug within three months prior to the screening visit
- Simultaneous participation in any other clinical intervention trial until completion of follow-up visit (V6)
- Treatment with any therapy, including endoscopic procedures and/or medication (e.g. liraglutide, bupropion/naltrexone and orlistat), intended for weight management within three months prior to the screening visit
- Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements
- Treatment with glucose-lowering agents within three months prior to the screening visit
- Use of GLP-1RAs, glucagon-like peptide 2 receptor agonists, dipeptidyl peptidase 4 (DPP4) inhibitors, human growth hormone, somatostatin or analogues thereof, within three months prior to screening visit
- Treatment with antipsychotics known to modulate energy intake three months prior to screening visit
- Prolonged treatment (>1 week) with anti-inflammatory agents or any PDE4 inhibition within three months prior to the screening visit
- Glycated haemoglobin (HbA1c) ≥ 48 mmol/mol at the screening visit
- Compromised kidney function (estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2) at screening visit
- Known liver disease (except for MASLD) at screening visit. Elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal
- History or evidence of hepatitis B virus infection
- Evidence of hepatitis C virus (HCV) infection. Confirmatory testing for HCV RNA will be conducted for participants who have a positive test result. Participants who have a negative result for HCV RNA will be eligible to participate in the trial
- Any type of bariatric surgery
- Known human immunodeficiency virus (HIV) positive or evidence positive for HIV antibodies (HIV-1 or HIV-2)
- Uncontrolled thyroid disease as per the discretion of the investigators
- Positive urine human chorionic gonadotropin (hCG) (for fertile women). Regarding fertile men and women: Women who are pregnant, intend to become pregnant, or are breastfeeding will not be included in the study. Sterilised or postmenopausal women (> 12 months amenorrhoea or females ≥ 60 years of age) can be included without the hCG-testing during the trial period. Female of childbearing potential: To exclude pregnancy, urine hCG tests are performed every fourth week after V2 (Week 4, 8, 12, 16 and 20). The following contraceptive methods are considered adequate for study enrolment for females if maintained throughout the study duration: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a monogamous relationship with a sterilized partner, or sexual abstinence.
- Previous, current or planned (during the trial period) obesity treatment with surgery or a weight loss device < 12 months prior to the screening visit
- History of type 1 diabetes or type 2 diabetes
- History of acute or chronic pancreatitis
- History and/or family history of medullary carcinoma and/or multiple endocrine neoplasia syndrome
- History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least five years
- History of major cardiovascular events three months prior to screening visit, including myocardial infarction, stroke, hospitalisation for angina and transient ischaemic attack
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.