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NCT04994288
A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients(SUPER-1)
Phase 2, PHASE3 trial testing Supaglutide injection in Type2 Diabetes in 547 participants. Completed in 16 August 2023.
20 June 2023
Quick facts
| Lead sponsor | Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 547 |
| Start date | 3 August 2021 |
| Primary completion | 20 June 2023 |
| Estimated completion | 16 August 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Supaglutide injection — full drug profile →
- placebo injection
Conditions studied
- Type2 Diabetes — all drugs for Type2 Diabetes →
Sponsor
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a study to evaluate the efficacy and safety of Supaglutide injection in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention. This trial includes dosage determination (Phase IIb) and efficacy confirmation stage(Phase III). The primary outcome of the phase IIb period is to preliminarily evaluate the efficacy and safety of Supaglutide and to provide the recommended dosage for the Phase 3 period after 12-week treatment. The primary outcome of the Phase III period is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blind treatment. The secondary outcome is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blinded plus 28-week, open-label treatment period.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes.
Lou YR, Xu YL, Xiong Y, Deng C, et al · · 2025 · cited 10× · PMID 39961992 · DOI 10.1007/s40262-025-01475-7 -
Efficacy and safety of efsubaglutide alfa in individuals with type 2 diabetes (SUPER1): a randomised, double-blind, placebo-controlled, Phase IIb/III trial.
Zhu D, Ma J, Wang W, Shi B, et al · · 2026 · cited 4× · PMID 41272211 · DOI 10.1007/s00125-025-06593-2 -
Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Mellitus.
Wang Q, Jiang F, Xu Y, Lei Y, et al · · 2025 · cited 2× · PMID 41107649 · DOI 10.1007/s40262-025-01570-9 -
Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial.
Zhu D, Wang W, Tong G, Ma J, et al · · 2026 · cited 1× · PMID 41501026 · DOI 10.1038/s41467-025-68165-7
Verify or expand the search:
- PubMed search for NCT04994288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Supaglutide injection
Trials testing the same drug.
- NCT05694221 — Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin · Phase 1 · completed
- NCT03745885 — A Study of the Efficacy and Safety of Supaglutide in Healthy Participants · Phase 1 · completed
Other recruiting trials for Type2 Diabetes
Currently open trials in the same condition.
- NCT05277558 — Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D) · recruiting
- NCT05015283 — Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission · NA · recruiting
- NCT05006508 — Prevention With the Health and Lifestyle Tool · NA · active not recruiting
- NCT04717050 — Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity · NA · active not recruiting
- NCT05220917 — Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study · active not recruiting
Other Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT07518121 — A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil · Phase 1 · not yet recruiting
- NCT07114419 — The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE） · Phase 2 · recruiting
- NCT06900075 — Efficacy and Safety of Efsubaglutide Alfa Injection 3 Mg Q2W in T2D Patients · Phase 3 · not yet recruiting
- NCT06921486 — The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (ENLIGHT) · Phase 2, PHASE3 · active not recruiting
- NCT06849843 — A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients. · Phase 2 · 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 NCT04994288 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
- Last refreshed: 7 August 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/NCT04994288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing