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

Regeneron Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Overweight or Obesity

Treatments: Drug: Olatorepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07685808

HS-20094-OB-25106

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

360 participants in 6 patient groups

Olatorepatide arm 1

Experimental group

Treatment:

Drug: Olatorepatide

Olatorepatide arm 2

Experimental group

Treatment:

Drug: Olatorepatide

Olatorepatide arm 3

Experimental group

Treatment:

Drug: Olatorepatide

Olatorepatide arm 4

Experimental group

Treatment:

Drug: Olatorepatide

Olatorepatide arm 5

Experimental group

Treatment:

Drug: Olatorepatide

Matching Placebo arm 6

Active Comparator group

Treatment:

Drug: Placebo