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CompletedNCT02070510Updated Feb 17, 2020

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

A Phase 1 interventional study of semaglutide and lisinopril in Diabetes and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.

02

Conditions studied

  • Diabetes
  • Healthy
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female aged 18-75 years (both inclusive) at time of signing informed consent
  • Body mass index 20.0-29.9 kg/m\^2 (both inclusive)
  • A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion criteria

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
  • History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit, a repeated measurement is allowed
  • Any blood draw in excess of 50 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Victim and perpetrator compounds

    Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.

    Drug: semaglutide · Drug: lisinopril · Drug: warfarin · Drug: placebo

Interventions

  • Drugsemaglutide

    For oral administration once daily. Doses of 5 mg and 10 mg, respectively, will be given for 7 days followed by 20 mg administered on days 43-84.

  • Druglisinopril

    For oral administration. A single dose of 20 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 1, 15 and 71).

  • Drugwarfarin

    For oral administration. A single dose of 5 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 8, 22 and 78).

  • Drugplacebo

    A single dose of SNAC is administered conconmitantly with victim compounds (days 15 and 22).

06

What researchers measure

Primary outcomes

  1. Area under the S-warfarin concentration-time curve

    Time frame: From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points

  2. Area under the R-warfarin concentration-time curve

    Time frame: From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points

  3. Area under the lisinopril concentration-time curve

    Time frame: From dosing to infinity calculated from a 0-60 hours lisinopril concentration-time-curve based on 13 sampling time points

Secondary outcomes

  1. Maximum observed S-warfarin plasma concentration

    Time frame: 0 to 168 hours after single dose

  2. Maximum observed R-warfarin plasma concentration

    Time frame: 0 to 168 hours after single dose

  3. Maximum observed lisinopril plasma concentration

    Time frame: 0 to 60 hours after single dose

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Berlin, 14050, Germany
08

References and documents

Publications

  • Baekdal TA, Borregaard J, Hansen CW, Thomsen M, Anderson TW. Effect of Oral Semaglutide on the Pharmacokinetics of Lisinopril, Warfarin, Digoxin, and Metformin in Healthy Subjects. Clin Pharmacokinet. 2019 Sep;58(9):1193-1203. doi: 10.1007/s40262-019-00756-2. PubMed 30945118 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02070510
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 25, 2014
Start date
Feb 27, 2014
Primary completion
Aug 20, 2014
Completion
Aug 20, 2014
Last update
Feb 17, 2020

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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