NL-OMON48226CompletedPhase 2
A TRIAL TO COMPARE THE INJECTION SITE PAIN EXPERIENCE OF 0.25 MG SEMAGLUTIDE SC ADMINISTERED BY 2 DIFFERENT PRODUCTS - SDD injection pain experience trial
ovo Nordisk0 sites104 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 104
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Male or female subjects, aged 18 to 75 years (both inclusive) at the time of
- •signing informed consent
- •- Body mass index (BMI) equal to or above 25.0 kg/m^2
- •- Considered to be generally healthy based on the medical history, physical
- •examination, and the results of vital signs, electrocardiogram (ECG), and
- •clinical laboratory tests performed during the screening visit, as judged by
- •the Investigator
Exclusion Criteria
- •- Woman who is pregnant or breast-feeding or intends to become pregnant within
- •4 weeks after administration of the study drug, or is of childbearing potential
- •and not using highly effective contraceptive methods with her fertile male
- •sexual partner
- •- Any disorder that in the Investigator's opinion might jeopardize subject's
- •safety, evaluation of results, or compliance with the protocol
- •- Glycosylated hemoglobin >=6.5% at screening
- •- Use of prescription medicinal products or non-prescription drugs or herbal
- •products, except routine vitamins, topical medication, contraceptives, and
- •occasional use of paracetamol (paracetamol not allowed within 24 hours prior to
- •drug administration), within 14 days prior to drug administration
- •- Average intake of more than 21 units of alcohol per week for male subjects
- •and more than 14 units per week for female subjects: 1 unit of alcohol equals
- •approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits
- •- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
- •antidepressants, and alcohol) at screening and admission to the clinical
- •research center
- •- Use of tobacco and nicotine products, defined as any of the below:
- •a) Smoking more than 1 cigarette or the equivalent per day on average
- •b) Not able or willing to refrain from smoking and the use of nicotine
- •substitute products during the inhouse period
- •- Subject is not able to understand and read English or Dutch, or subject
- •is not able to understand and comply with the study requirements
Investigators
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