This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.
The study is looking at:
* What side effects the study drug might cause
* How much study drug is in the blood at different times
* How well the study drug works
* What effects the study drug may have on the body at different dosing schedules
* If the body makes antibodies to the study drug as this may cause the study drug to not work as well
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
1. Body Mass Index (BMI) ≥30.0 kg/m\^2 to \<45.0 kg/m\^2 at screening OR
2. BMI ≥27.0 kg/m\^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol
Key Exclusion Criteria:
1. Previous or current diagnosis of Type 1 or Type 2 diabetes at screening
2. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol
3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol
4. History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones
5. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Primary outcome measure(s)
Occurrence of Treatment-Emergent Adverse Events (TEAEs) — Up to approximately 60 weeks
Severity of TEAEs — Up to approximately 60 weeks
Percent change in body weight — From baseline to week 52
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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