IBI3042 Study in Healthy Participants and Overweight or Obese Participants

What Was Tested

This registered phase 1 trial tested Orforglipron (Foundayo, non-peptide).

This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity.

The study has two parts.

It had five arms (groups): Investigational Drug: IBI3042 (Part A) (experimental), Investigational Drug: IBI3042 (Part B) (experimental), Matching Placebo (Part B) (placebo comparator), Orforglipron (Part B) (active comparator) and Matching Placebo (Part A) (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 104 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 18 to 55 years, inclusive. For Part A: BMI ≥20 and \<30 kg/m\^2 and body weight ≥50 kg. For Part B: BMI ≥24 and ≤40 kg/m\^2, with stable body weight during the 3 months prior to screening. Able and willing to comply with study procedures and voluntarily provide written informed consent.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: known or suspected hypersensitivity to any component of the study drug or to glp-1 receptor agonists; history of diabetes or abnormal glycemic parameters at screening; personal or family history of thyroid c-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (men 2a or 2b), or calcitonin ≥20 ng/l at screening.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Orforglipron (Foundayo, non-peptide) group and the comparison group should start out alike.

The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Orforglipron (Foundayo, non-peptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2026-09-07 with completion listed for 2027-09-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Adverse Events (Part A) (time frame: through study completion, an average of 29 days). Number of Participants With Abnormal Physical Examination Findings (Part A) (time frame: through study completion, an average of 29 days). Number of Participants With Adverse Events (Part B) (time frame: through study completion, an average of 113 days).

It also tracked 15 secondary outcomes, for example Area Under the Plasma Concentration?Time Curve (AUC) (Part A), Peak Plasma Concentration (Cmax) (Part A), Time to Reach Peak Plasma Concentration (Tmax) (Part A), Apparent Clearance (CL/F) (Part A), Apparent Volume of Distribution (Vz/F) (Part A) and Terminal Half-Life (T1/2) (Part A).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Orforglipron (Foundayo, non-peptide) in 104 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.