Drugs / Bofanglutide
Bofanglutide
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07128888 | Nov 2025 → Jul 2026 overdue | obesity disorder | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 1 | NCT07144098 | Aug 2025 → Jul 2026 overdue | obesity disorder | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 1 | NCT07119450 | May → Aug 2025 | obesity disorder | Gan & Lee Pharmaceuticals. | Completed | No outcome recorded |
| Phase 1 | NCT07141030 | Apr → Oct 2025 overdue | obesity disorder | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 1 | NCT06670209 | Oct 2024 → Mar 2025 overdue | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06554054 | Apr → Dec 2024 overdue | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06548945 | Apr → Aug 2023 | morbid obesity | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT05328726 | Mar 2022 → Feb 2023 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1 | NCT06548997 | Dec 2021 → Oct 2022 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06256536 | Jul 2022 → Oct 2023 | obesity disorder | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 1/2 | NCT06256523 | Jun 2022 → Sep 2023 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Completed | No outcome recorded |
| Phase 24 trials · 3 met primary | ||||||
| Phase 2 | NCT07055386 | Aug 2025 → Jun 2026 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06737042 | Feb 2025 → Feb 2026 | obesity disorder | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 2 | NCT06256549 | Aug 2023 → Jul 2024 | type 2 diabetes mellitus | Gan and Lee Pharmaceuticals, USA | Unknown | Met primary |
| Phase 2 | NCT06256562 | Jun 2023 → Jun 2024 | obesity disorder | Gan and Lee Pharmaceuticals, USA | Completed | Met primary |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT07622810 | Sep 2026 → Dec 2027 expected | obesity disorder | Carnot Laboratories | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07628985 | Sep 2026 → Oct 2027 expected | type 2 diabetes mellitus | Carnot Laboratories | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07493057 | Apr 2026 → Nov 2027 expected | obstructive sleep apnea syndrome | Gan & Lee Pharmaceuticals. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07501832 | Mar 2026 → Sep 2028 expected | obstructive sleep apnea syndrome | Gan & Lee Pharmaceuticals. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07292441 | Jan 2026 → Sep 2027 expected | obesity disorder | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 3 | NCT07150975 | Sep 2025 → Jun 2027 expected | — | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 3 | NCT06778967 | Feb 2025 → Dec 2026 expected | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06777238 | Jan 2025 → Aug 2026 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06728124 | Dec 2024 → May 2026 overdue | obesity disorder | Gan & Lee Pharmaceuticals. | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06974487 Comparator | May → Sep 2025 overdue | type 2 diabetes mellitus | Gan & Lee Pharmaceuticals. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-06-24 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Shines at CPHI China 2026, Securing Dual Honors for "R&D Innovation Awards" and "Sustainability Influencer Awards" ganlee.com ↗
Notably, the Company presented new clinical data at the recently concluded American Diabetes Association 86th Scientific Sessions (ADA 2026): The findings further support the use of bofanglutide and insulin ludefen injection |
| 2026-06-11 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals ADA 2026 Abstract Data Review | Multiple Metabolic Pipeline Research Results Presented at International Academic Conference ganlee.com ↗
In terms of safety, the incidence and severity of treatment-emergent adverse events (TEAE) were similar between the renal impairment groups and the normal renal function group. |
| 2026-06-10 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Showcases Multiple Innovative Research Achievements at the American Diabetes Association’s 86th Scientific Sessions ganlee.com ↗
The findings further support the use of bofanglutide injection and insulin ludefen injection in patients with renal impairment. |
| 2026-06-04 | Gan and Lee Pharmaceuticals, USA | Results 52 weeks, 18.54% weight loss achieved! Gan & Lee Pharmaceuticals’Biweekly GLP-1 RA Bofanglutide injection Meets Primary Endpoints in Both a Pivotal Phase 3 Weight Management Trial in China and a pivotal Phase II study in the United States. ganlee.com ↗
The results showed that after 52 weeks of treatment, participants receiving bofanglutide injection 24 mg and 48 mg achieved mean body weight reductions of 15.12% and 18.54%, respectively, compared with 1.11% in the placebo group. |
| 2026-03-04 | Gan and Lee Pharmaceuticals, USA | Results Featured in Top Journal | Gan & Lee Pharmaceuticals' Phase 2b Results of Bofanglutide (GZR18) Published in Signal Transduction and Targeted Therapy ganlee.com ↗
As a potentially first bi-weekly GLP-1 RA worldwide, the study results of bofanglutide injection demonstrated significant body-weight reduction, with comprehensive improvements in cardiometabolic and metabolic parameters. |
| 2025-07-01 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Presented Multiple Research Breakthroughs at the American Diabetes Association's 85th Scientific Sessions ganlee.com ↗
In a phase 2b clinical trial, the bofanglutide injection showed comparable or statistically significant HbA1c and body weight reduction than semaglutide (Ozempic ® ) after 24 weeks of bi-weekly treatment in patients with T2D, along with an good safety and tolerability profile. |
| 2025-06-21 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association’s 85th Scientific Sessions ganlee.com ↗
In a Phase 2b clinical trial, the bofanglutide injection showed superior HbA1c and body weight reduction than semaglutide (Ozempic ® ) after 24 weeks of bi-weekly treatment in patients with T2DM, along with an acceptable safety and tolerability profile. |
| 2025-05-29 | Gan and Lee Pharmaceuticals, USA | Results Multinational Diabetes Academic Conference 2025 Opens in Beijing, Gathering Global Experts to Explore New Trends in Prevention and Treatment ganlee.com ↗ |
| 2025-04-10 | Gan and Lee Pharmaceuticals, USA | Results Preview of Meeting | Gan & Lee Pharmaceuticals to Present Data from Multiple Clinical Studies of Bofanglutide and GZR4 Injection at the 85th American Diabetes Association Scientific Sessions (ADA 2025) ganlee.com ↗
Bofanglutide (GZR18), a Novel GLP-1 RA, Improved Glycemic Control and Cardiometabolic Risk Factors in Chinese Patients with T2D |
| 2025-03-08 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals' Phase 1 Study Results of Bofanglutide Injection Published in Diabetes, Obesity and Metabolism ganlee.com ↗
The studies demonstrated that Bofanglutide has a favorable safety and tolerability profile in healthy subjects from both the Chinese and U.S. populations, with no significant ethnic differences observed 1 . |
| 2024-11-13 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Announced Positive Phase 1 Results for Its Oral GLP-1 Receptor Agonist GZR18 Tablet in Healthy Participants, Demonstrating 4.16% Weight Reduction in Two Weeks ganlee.com ↗
Participants treated with the target dose of 60 mg daily for two weeks exhibited an average weight reduction of 4.16% from baseline. |
| 2024-11-12 | Gan and Lee Pharmaceuticals, USA | Results ObesityWeek®️ 2024 | Gan & Lee Pharmaceuticals Orally Presents Phase 2b Clinical Data for GZR18 Injection in Chinese Overweight and Obese Adults ganlee.com ↗
The clinical efficacy and safety of bi-weekly 48 mg and once-weekly 24 mg GZR18 injections were comparable, with no significant difference in mean percent change in body weight from baseline between the two groups (one-sided test, P > 0.025). |
| 2024-10-16 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies ganlee.com ↗
After 24 weeks of treatment in patients with Type 2 diabetes, the bi-weekly GLP-1 receptor agonist GZR18 injection showed superior efficacy in lowering HbA1c and body weight compared to semaglutide (Ozempic ® ). |
| 2024-07-22 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Bi-weekly（twice a month） GLP-1 Receptor Agonist GZR18 Injection Achieved 17.29% Weight Loss at 30 Weeks in a Phase IIb Clinical Trial ganlee.com ↗
Recently, Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that its independently developed long-acting GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved positive results in a clinical trial for adults with obesity/overweight in China. |
| 2024-07-11 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Successfully Shines at the American Diabetes Association's 84th Scientific Sessions ganlee.com ↗ |
| 2024-06-22 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals Announces Significant Progress on New Diabetes and Obesity Treatments at the American Diabetes Association's 84th Scientific Sessions ganlee.com ↗
The study results demonstrated a superior efficacy of GZR18 Injection than placebo for weight reduction in Chinese obese subjects. |
| 2023-12-01 | Gan and Lee Pharmaceuticals, USA | Regulatory Gan & Lee Pharmaceuticals Announces IND Clearance by the NMPA for the Oral GLP-1 Receptor Agonist (GZR18 Tablet) ganlee.com ↗
has received approval from the National Medical Products Administration (NMPA) for the clinical trial of its Class 1 innovative biological product, GZR18 Tablet |
All press releases naming this drug 27 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bofanglutide | “Bofanglutide (GZR18) is a long-acting GLP-1 receptor agonist administered by subcutaneous injection every 2 weeks.” NCT07622810 ↗ |
| Known as | Bofanglutida | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07622810 ↗ |
| Known as | GZR18 | “A Double-blind, Randomized, Placebo-controlled, Sequential, Single, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters...” NCT05328726 ↗ |
| Action | Activate | “GZR18 is a long-acting glucagon-like peptide-1 receptor agonist” PMID 42320483 ↗ Jun 2026 |
| Modality | Protein / enzyme biologic | — CHEMBL6068096 ↗ |
| Route | Subcutaneous | “GZR-18 administered once via subcutaneous injection” NCT05328726 ↗ |