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mazdutide glp 1 agonist rct n=60 2020-06-16 ClinicalTrials

IBI362 Phase 1/2 Study Evaluates Safety and PK/PD in Overweight and Obesity

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Background

Globally, obesity and overweight conditions represent significant public health challenges, contributing to an increased risk of numerous chronic diseases such as type 2 diabetes, cardiovascular disease, and certain cancers. The urgent need for effective and safe pharmacological interventions to manage weight is paramount. This randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of IBI362 in affected individuals.

Study Design

Population
60 participants with overweight or obesity.
Intervention
Multiple ascending doses of IBI362.
Comparator
Placebo.
Outcome
Safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IBI362.

Results

This completed Phase 1/2 study successfully enrolled its target of 60 participants, investigating IBI362 in individuals with overweight or obesity. The primary objectives of evaluating IBI362's safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) were thoroughly investigated across multiple ascending doses. While the trial's completion is noted, the provided research record does not detail specific findings regarding adverse events, precise PK parameters, or quantitative PD outcomes such as weight loss percentages or metabolic improvements. The study confirmed the feasibility of administering IBI362 in overweight or obese subjects, successfully completing its initial human evaluation phase. Without specific data, quantitative comparisons between IBI362 and placebo regarding efficacy or specific safety metrics cannot be made from this summary.

Why It Matters

The successful completion of this Phase 1/2 study marks a critical developmental milestone for IBI362 as a potential therapeutic agent for overweight and obesity. Establishing the initial safety profile and understanding the pharmacokinetic/pharmacodynamic characteristics in humans is an indispensable step for advancing novel drug candidates. This foundational data will be instrumental in informing the design and progression of larger, pivotal clinical trials aimed at definitively assessing IBI362's efficacy in weight management and related metabolic conditions. The next crucial steps will involve Phase 2 and Phase 3 human trials to further evaluate efficacy, optimal dosing, and long-term safety.


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Source: clinicaltrials:NCT04440345 · Ingested 2026-04-27 · Digest: gemini-2.5-flash