NCT07685808

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
16mo left

Started Jul 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Jan 2028

First Submitted

Initial submission to the registry

June 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

July 28, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2028

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

June 29, 2026

Last Update Submit

September 28, 2026

Conditions

Overweight or Obesity

Keywords

Body weightGlucagon-Like Peptide-1 (GLP-1)/Gastric inhibitory polypeptide (GIP) receptor agonistDose-findingControl appetite

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Olatorepatide concentrations

    Up to approximately 60 weeks

  • Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

    Up to approximately 52 weeks

  • Magnitude of ADA to olatorepatide

    Up to approximately 52 weeks

Study Arms (6)

Olatorepatide arm 1

EXPERIMENTAL
Drug: Olatorepatide

Olatorepatide arm 2

EXPERIMENTAL
Drug: Olatorepatide

Olatorepatide arm 3

EXPERIMENTAL
Drug: Olatorepatide

Olatorepatide arm 4

EXPERIMENTAL
Drug: Olatorepatide

Olatorepatide arm 5

EXPERIMENTAL
Drug: Olatorepatide

Matching Placebo arm 6

ACTIVE COMPARATOR
Drug: Placebo

Interventions

OlatorepatideDRUG

Administered per the protocol

Also known as: HS-20094
Olatorepatide arm 1Olatorepatide arm 2Olatorepatide arm 3Olatorepatide arm 4Olatorepatide arm 5
PlaceboDRUG

Administered per the protocol

Matching Placebo arm 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) ≥30.0 kg/m\^2 to \<45.0 kg/m\^2 at screening OR
  • 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

You may not qualify if:

  • 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
  • History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

AMR Clinical - Mobile

Mobile, Alabama, 36608, United States

RECRUITING

Diablo Clinical Research - Flourish Research

Walnut Creek, California, 94598, United States

RECRUITING

AMR Clinical - Miami

Doral, Florida, 33172, United States

RECRUITING

AMR Clinical - Fort Myers

Fort Myers, Florida, 33912, United States

RECRUITING

AGA Clinical Trials

Hialeah, Florida, 33012, United States

RECRUITING

Flourish Research, Nature Coast Clinical Research

Inverness, Florida, 34452, United States

RECRUITING

Flourish Research, Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

K2 Medical Research Maitland LLC, Main Office

Maitland, Florida, 32751, United States

RECRUITING

IMA Clinical Research St. Petersburg

St. Petersburg, Florida, 33704, United States

RECRUITING

Charter Research LLC - The Villages

The Villages, Florida, 32162, United States

RECRUITING

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida, 32789, United States

RECRUITING

Charter Research LLC - Chicago

Chicago, Illinois, 60618, United States

RECRUITING

Flourish Research - Chicago

Chicago, Illinois, 60625, United States

RECRUITING

AMR Clinical - Chicago Oak Brook

Oak Brook, Illinois, 60523, United States

RECRUITING

AMR Clinical - Wichita

Wichita, Kansas, 67207, United States

RECRUITING

AMR Clinical - Lexington

Lexington, Kentucky, 40509, United States

RECRUITING

Rochester Clinical Research

Rochester, New York, 14609, United States

RECRUITING

Tribe Clinical Research

Greenville, South Carolina, 29607, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643clinicaltrials@regeneron.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 6, 2026

Study Start

July 28, 2026

Primary Completion (Estimated)

January 21, 2028

Study Completion (Estimated)

January 21, 2028

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
More information

Locations

US(18)