Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: semaglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02557620

2014-005171-84 (EudraCT Number)

NN9535-4215

U1111-1164-2741 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.

Enrollment: 113 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
• Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
• HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
• History of pancreatitis (acute or chronic)
• Screening calcitonin equal or above 50 ng/L
• Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 3 patient groups, including a placebo group

semaglutide OD + placebo semaglutide OW

Experimental group

Treatment:

Drug: semaglutide

Drug: placebo

placebo semaglutide OW + placebo semaglutide OD

Placebo Comparator group

Treatment:

Drug: placebo

semaglutide OW + placebo semaglutide OD

Experimental group

Treatment:

Drug: semaglutide

Drug: placebo