NCT07242664

Brief Summary

This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Type 1 Diabetes Mellitis

Outcome Measures

Primary Outcomes (1)

  • the relative potency of GZR33 to insulin degludec

    Primary endpoint will be the relative potency of GZR33 to insulin degludec, according to the following equation: Relative Potency = GIR24h,ss,GZR33 /GIR24h,ss,degludec) × (Dosedegludec/DoseGZR33).

    a two week run-in phase

Study Arms (2)

Period 1 - GZR-33, period 2 insulin degludec

EXPERIMENTAL

Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days

Drug: GZR-33

Period 1 - insulin degludec, period 2 - GZR-33

EXPERIMENTAL

Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days

Drug: GZR-33

Interventions

GZR-33DRUG

GZR33 is a long-acting basal insulin analogue

Period 1 - GZR-33, period 2 insulin degludecPeriod 1 - insulin degludec, period 2 - GZR-33

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • HbA1c \<= 9.0%.
  • Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2
  • treated with a stable insulin regimen for at least 2 months, in a dose \> 0.2 and \< 1.2 U/kg/day

You may not qualify if:

  • blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic)
  • clinically significant concomitant diseases
  • recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening)
  • hypoglycemia unawareness
  • estimated glomerular filtration rate (eGFR) \<60.0 mL/min/1.73 m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Profil Institut

Neuss, 41460, Germany

RECRUITING

Profil

Neuss, Germany

RECRUITING

Central Study Contacts

Andre Feldmann

CONTACT

+49 (0) 2131 4018 409149-1226-GZR-33@profil.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

October 13, 2025

Primary Completion

February 28, 2026

Study Completion

April 15, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations

DE(2)