Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05689099 · ClinicalTrials.gov registry record · Phase 1
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose
A Phase 1 study of Diabetes Mellitus, Type 2 and Healthy Participants, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05689099 is a Phase 1 study of Diabetes Mellitus, Type 2 and Healthy Participants that has completed, run by Novo Nordisk A/S. The registered enrollment target is 20 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05689099, a Phase 1 study of Diabetes Mellitus, Type 2 and Healthy Participants, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Conditions Studied
Interventions
- DRUG Semaglutide B, 1.34 mg/mL
- DRUG Semaglutide B, 0.68 mg/mL
Study Locations (1)
California
- Altasciences Clinical LA, Inc. - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-17 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05689099
The ClinicalTrials.gov registry entry for NCT05689099 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Semaglutide B, 1.34 mg/mL is the first listed.
NCT05689099 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05689099 about?
NCT05689099 is a clinical study titled "A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose". In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved se...
What is the current status of trial NCT05689099?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-01-17. Estimated completion is 2023-05-30.
What conditions does trial NCT05689099 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Healthy Participants.
What interventions are being tested in trial NCT05689099?
The interventions under investigation include: Semaglutide B, 1.34 mg/mL (DRUG), Semaglutide B, 0.68 mg/mL (DRUG).
Who is sponsoring clinical trial NCT05689099?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05689099 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
RECRUITING · Phase 1
-
Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)
RECRUITING · Phase 1
-
Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
ACTIVE NOT RECRUITING · Phase 1
-
Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes
ACTIVE NOT RECRUITING · Phase 1
-
A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
ACTIVE NOT RECRUITING · Phase 1
-
Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
COMPLETED · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.