IBI3032 / Innovent Biologics - LARVOL DELTA

A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032, a Novel Oral Nonpeptide GLP-1 Receptor Agonist: Single- and Multiple-Ascending Dose Studies in Chinese Adults (ADA 2026) - P1 | "IBI3032 demonstrated a favourable safety, tolerability, and PK profile. Preliminary data showed significant body weight reductions with multiple doses, supporting the continued clinical development of IBI3032 as a novel oral GLP-1 agent."

Clinical • First-in-human • PK/PD data • Metabolic Disorders • Obesity

IBI3032: An Orally Bioavailable Nonpeptidic GLP-1 Receptor Agonist Advancing through Phase 1 Clinical Trials (ADA 2026) - "IBI3032 is a potent, selective oral GLP-1R agonist with favorable pharmacokinetics, robust and dose-dependent weight loss in preclinical models, and is currently being evaluated in Phase 1 clinical trials as a once-daily oral therapy for type 2 diabetes and obesity."

Clinical • P1 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

ADA Reference: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032, a Novel Oral Nonpeptide GLP-1 Receptor Agonist: Single- and Multiple-Ascending Dose Studies in Chinese Adults (Abstract No.: 1690-P) (PRNewswire) - "After a single oral dose, IBI3032's systemic exposure (AUCinf and Cmax) increased in an approximately dose-proportional manner across 0.3–6 mg dose range; peak plasma concentration (Tmax) occurred 5–12 hours post-dose. Its terminal elimination half-life is (T1/2) approximately 2 days, which supports a once-daily dosing regimen. Pharmacokinetics (PK) parameters after 4 weeks of sequential titration in MAD were consistent with SAD and exhibited linear PK characteristics...IBI3032 showed a manageable safety profile in both SAD and MAD studies...Four-week cohort comparisons within MAD study demonstrated that low starting dose with stepwise dose escalation enables substantial weight reduction alongside meaningful improvement in gastrointestinal tolerability. In the cohort starting at 0.6 mg with seven-step escalation to 9 mg (n=12), 4-week treatment led to an average 10.11% body weight reduction after 4 weeks, while vomiting incidence remained at 8.3%."

P1 data • PK/PD data • Obesity

ADA Reference: IBI3032: An Orally Bioavailable Nonpeptidic GLP-1 Receptor Agonist Advancing Through Phase 1 Clinical Trials (Abstract No.: 1678-P) (PRNewswire) - "IBI3032 exhibited potent activation of the human GLP-1R (EC₅₀ = 0.53 nM) with high selectivity and minimal β-arrestin recruitment. IBI3032 demonstrated favorable cross‑species pharmacokinetics and a robust preclinical efficacy profile. Pharmacokinetic studies revealed high oral exposure in cynomolgus monkeys, with a bioavailability of 24.5% and a half-life of 6.3 hours....Importantly, compared to the marketed small‑molecule GLP‑1R agonist Orforglipron, IBI3032 demonstrates significantly superior weight‑loss efficiency—achieving markedly greater body weight loss at half of the dose in preclinical models. In a 28-day study in hGLP-1R knock-in DIO mice, oral IBI3032 produced dose-dependent body weight loss relative to vehicle (1 mg/kg: -1.8%; 6 mg/kg: -8.0%; 12 mg/kg: -10.8%). In a 28-day cynomolgus monkey study, once-daily oral administration of IBI3032 (1 mg/kg) produced 11.2% body weight loss versus vehicle."

Preclinical • Obesity

Innovent to Present Multiple Clinical and Preclinical Results of Mazdutide and Next-Generation Obesity & Metabolic Pipeline at the 2026 ADA Scientific Sessions (PRNewswire) - "'The multiple oral presentations of mazdutide, across adults with type 2 diabetes and obesity, adults with obesity and adolescents with obesity, further highlight its differentiated profile as a GCG/GLP‑1 dual receptor agonist in terms of weight loss, glycemic control and metabolic benefits. In addition, the data on IBI3032 (oral daily GLP-1 small molecule), IBI3042 (oral weekly GLP-1 small molecule), IBI3040 (amylin) and IBI3046 (INHBE siRNA) represent key milestones of our next‑generation obesity pipeline with global potential...'"

Clinical data • P3 data • Preclinical • Obesity • Type 2 Diabetes Mellitus

A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Trial completion date: Mar 2026 ➔ Sep 2026 | Trial primary completion date: Nov 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study of IBI3032 in Chinese Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=79 | Active, not recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study of IBI3032 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Active, not recruiting ➔ Completed

Trial completion

A Study of IBI3032 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of IBI3032 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Fortvita Biologics (USA)Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of IBI3032 in Chinese Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

New P1 trial • Genetic Disorders • Obesity

A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=92 | Not yet recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

New P1 trial • Genetic Disorders • Obesity

A Study of IBI3032 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of IBI3032 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Fortvita Biologics (USA)Inc.

New P1 trial

A Study of IBI3032 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

New P1 trial

Innovent Receives U.S. FDA Approval for IND Application of Oral GLP-1R Agonist IBI3032 (PRNewswire) - "Innovent Biologics...announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to initiate a Phase 1 clinical trial of IBI3032, the company's novel oral GLP-1R agonist....The Phase 1 clinical trials of IBI3032 are planned to be conducted concurrently in China and the U.S. Dosing in healthy volunteers and overweight or obese participants is expected to begin in the second half of 2025."

IND • New P1 trial • Obesity