This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.

Inclusion Criteria:

• Signed informed consent
• BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

Exclusion Criteria:

• Previous documented diagnosis of diabetes mellitus.
• Self-reported change in body weight >5% within 3 months before Screening
• Body weight ≤80 kg at Screening
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)

De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request

Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Gasherbrum Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes:

• re-evaluating safety and efficacy end points already addressed in the product labelling,
• assessing safety or efficacy for an indication in current development

Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.