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

Phase 2Not Yet RecruitingNCT07685808

Regeneron Pharmaceuticals360 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

360

Conditions

Overweight or Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to approximately 60 weeks

Severity of TEAEs

Time frame: Up to approximately 60 weeks

Percent change in body weight

Time frame: From baseline to week 52

Secondary Outcomes

Olatorepatide concentrations

Time frame: Up to approximately 60 weeks

Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

Time frame: Up to approximately 52 weeks

Magnitude of ADA to olatorepatide

Time frame: Up to approximately 52 weeks

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts