Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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 criteria

Qualifiers

Body Mass Index (BMI) ≥30.0 kg/m² to <45.0 kg/m² at screening OR

BMI ≥27.0 kg/m² 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

Disqualifiers

Previous or current diagnosis of Type 1 or Type 2 diabetes at screening

Change in body weight >5 kg within approximately 3 months before screening as described in the protocol

Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol

History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones

Trial design

Treatments tested in this trial

  • Olatorepatide
  • Placebo

Treatment groups

360 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators