Clinical trial NCT02079870 (phase 1, status: completed)
Conditions: diabetes, metabolism and nutrition disorder, obesity
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65, E70.5, E71.32, E72.4, E76.9, E78.89, E83.2, E88.40, E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: semaglutide, placebo
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)C(C)(C)NC(=O)[C@@H](N)CC1=CNC=N1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age above or equal to 18 years at the time of signing informed consent

          -  HbA1c (glycosylated haemoglobin A1c) below 6.5%

          -  A BMI (body mass index) between 30-45 kg/m^2 (both inclusive)

        Exclusion Criteria:

          -  Females who are pregnant, breast-feeding or intend to become pregnant or is of
             childbearing potential and not using adequate contraceptive method (adequate
             contraceptive measures as required by local law or practice, UK requirements: adequate
             contraceptive measures are defined as established use of oral, injected or implanted
             hormonal methods of contraception, sterilisation, intrauterine device or intrauterine
             system, or consistent use of barrier methods together with the use of spermicide, and
             sexual abstinence)

          -  Any disorder which, in the opinion of the investigator, might jeopardise subject's
             safety or compliance with the protocol

          -  Diagnosis of type 1 or 2 diabetes mellitus

          -  Anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the
             trial

          -  Use of any prescription or non-prescription medication which could interfere with
             trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or
             specifically: 1) within 12 months prior to screening any weight lowering
             pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic
             corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic
             antidepressants, atypical antipsychotic and mood stabilizers, 2) within 3 months prior
             to screening use of statins, antihyperlipidemics including fibrates or nicotinic acid
             and its derivates, 3) supplementation with omega 3 fatty acids from 1 month prior to
             screening, 4) co-treatment with antihypertensive drugs is allowed if treatment has
             been stable for at least 1 month prior to screening and treatment should be kept
             unchanged during the trial

          -  Significant history of alcoholism or drug/chemical abuse within 1 year from screening,
             or a positive result of the urine drug screen or alcohol breath test, or consuming
             more than 21 units of alcohol per week for females and 28 units of alcohol per week
             for males (1 unit of alcohol equals ½ pint [285 mL] of beer or lager, 1 glass [125 mL]
             of wine, or 1/6 gill [25 mL] of spirits)

          -  Smoking or use of any nicotine products (including nicotine patches, gum etc.) in the
             last 3 months prior to screening or a positive cotinine test