Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Ecnoglutide Monotherapy in T2DM Inadequately Controlled by Diet and Exercise
NCT05680155Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2022
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- Sciwind Biosciences
- Modality
- Peptides
- Drugs
- ecnoglutide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of ecnoglutide in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Sciwind Biosciences. Primary endpoint: Change from baseline in HbA1c at 24 weeks. Started Dec 2022; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Ecnoglutide High Dose
Ecnoglutide 1.2 mg once weekly.
Ecnoglutide Low Dose
Ecnoglutide 0.6 mg once weekly.
Placebo High Match
Placebo matching high dose.
Placebo Low Match
Placebo matching low dose.
03
Who it enrols
Adult patients with T2DM inadequately controlled by diet and exercise alone (HbA1c 7.5-11.0%), BMI 20-35 kg/m2. Excludes recent GLP-1 use, T1DM, pancreatitis history, and severe CV events.
04
Endpoints
Primary
Change from baseline in HbA1c
Secondary
Change from baseline in HbA1c
Proportion of subjects with HbA1c < 7% and HbA1c <= 6.5%
Proportion of subjects with HbA1c < 7% with no severe hypoglycemia or no weight gain
Change from baseline in fasting plasma glucose
Change from baseline in fasting insulin
Change from baseline in lipid panel
Change from baseline in 2-hour postprandial blood glucose
Change from baseline in body weight
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT05680155.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05680155.