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NCT06256523
A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)
Phase 1, PHASE2 trial testing GZR18 in Type 2 Diabetes in 72 participants. Completed in 28 September 2023.
28 September 2023
Quick facts
| Lead sponsor | Gan and Lee Pharmaceuticals, USA |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 29 June 2022 |
| Primary completion | 28 September 2023 |
| Estimated completion | 28 September 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- GZR18 — full drug profile →
- Placebo
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Gan and Lee Pharmaceuticals, USA — full company profile →
Who can join
Adults 18 to 65, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06256523
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GZR18
Trials testing the same drug.
- NCT07150975 — Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese o · Phase 3 · recruiting
- NCT06778967 — A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus · Phase 3 · active not recruiting
- NCT06737042 — Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants · Phase 2 · not yet recruiting
- NCT06777238 — A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Melli · Phase 3 · active not recruiting
- NCT06554054 — A Study of GZR18 Tablet in Chinese Healthy Subjects · Phase 1 · active not recruiting
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Gan and Lee Pharmaceuticals, USA trials
Trials by the same sponsor.
- NCT07242664 — Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State · Phase 1 · recruiting
- NCT07146347 — Comparison Study of Insulin GZR4 With Insulin Degludec · Phase 1 · recruiting
- NCT06737042 — Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants · Phase 2 · not yet recruiting
- NCT06670209 — A Phase I Clinical Study to Evaluate the Effect of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochlori · Phase 1 · not yet recruiting
- NCT06547502 — Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06256523 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gan and Lee Pharmaceuticals, USA
- Last refreshed: 23 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06256523.
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