SAD: subcutaneous injection in the abdomen / Healthy Participants / Overweight Or Obese Participants · Phase 1 Trial

Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 clinical trial registration for IBI3040, a drug candidate not yet studied in humans. The trial plans to assess safety and tolerability through single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants. No results are yet available in this registry record.

What was studied

Phase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Healthy Participants, Overweight or Obese Participants; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: IBI3040. Compared with: IBI362 — Active Comparator; IBI3040 Placebo — Placebo Comparator. n = 96. 1 site: China.

Key findings

Safety

No efficacy endpoints are planned; safety and tolerability only.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1 trial registration with no reported results; it describes a planned study of safety and tolerability in healthy and overweight/obese participants.

Study design

As stated by the source record.

MethodsPrimary outcome measures: SAD: The incidence rate of adverse events (AE) (assessed at through study completion, an average of 60 days); SAD: The incidence rate of serious adverse events (SAE) (assessed at through study completion, an average of 60 days); SAD: Number of subjects with clinically significant changes in physical examination results (assessed at through study completion, an average of 60 days); SAD: Number of subjects with clinically significant changes in vital signs (assessed at through study completion, an average of 60 days); SAD: Number of participants with abnormal laborator…

DesignPhase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationHealthy Participants, Overweight or Obese Participants; age from 18 Years; to 65 Years; accepts healthy volunteers

Sample size96

InterventionIBI3040

ComparatorIBI362 — Active Comparator; IBI3040 Placebo — Placebo Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment96

PhasePHASE 1

Recruitment statusNOT_YET_RECRUITING

SAD follow-up durationan average of 60 days

MAD follow-up durationan average of 20 weeks

Primary outcome measure (SAD/MAD)Incidence rate of adverse events (AE), serious adverse events (SAE), clinically significant changes in physical examination, vital signs, laboratory tests, and electrocardiogram

Caveats

This is a registry record only; no results are posted and the trial has not yet begun recruitment.
Blinding, randomisation method, and comparator details are not stated in the registry record.
No efficacy endpoints are planned; safety and tolerability only.
Results are not available to inform clinical decision-making.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1, single- and multiple-dose design; registration only, no results posted.

Directness

limited

Safety endpoints only; no efficacy outcomes planned or reported.

Consistency

insufficient

No results available to assess consistency with other studies.

Risk of bias

insufficient

Study design not yet complete; blinding, randomisation details not stated.

Sample adequacy

limited

96 participants estimated; typical for early Phase 1 but underpowered for safety signals.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07765160). This is a study registration, not published results. Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 96 participants (ESTIMATED). Conditions: Healthy Participants, Overweight or Obese Participants. Interventions: DRUG: SAD: subcutaneous injection in the abdomen; DRUG: MAD: subcutaneous injection in the abdomen. Primary outcome measures: SAD: The incidence rate of adverse events (AE) , through study completion, an average of 60 days; SAD: The incidence rate of serious adverse events (SAE) , through study completion, an average of 60 days; SAD: Number of subjects with clinically significant changes in physical examination results , through study completion, an average of 60 days; SAD: Number of subjects with clinically significant changes in vital signs , through study completion, an average of 60 days; SAD: Number of participants with abnormal laboratory tests results , through study completion, an average of 60 days; SAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram , through study completion, an average of 60 days; MAD: The incidence rate of adverse events (AE) , through study completion, an average of 20 weeks; MAD: The incidence rate of serious adverse events (SAE) , through study completion, an average of 20 weeks; MAD: Number of subjects with clinically significant changes in physical examination results , through study completion, an average of 20 weeks; MAD: Number of subjects with clinically significant changes in vital signs , through study completion, an average of 20 weeks; MAD: Number of participants with abnormal laboratory tests results , through study completion, an average of 20 weeks; MAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram , through study completion, an average of 20 weeks. Brief summary: Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

SAD: subcutaneous injection in the abdomenNCT07765160Healthy ParticipantsInnovent Biologics (Suzhou) CoOverweight Or Obese ParticipantsMAD: subcutaneous injection in the abdomen