Recent Updates
Recently added Catalysts

Olatorepatide

Phase 2

Overweight or Obesity | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 20, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment480

FDA Designations

No designations recorded

Clinical trial landscape

Olatorepatide · 2 trials · 1 indication

Phase 2 2
NCT07685808Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without DiabetesOverweight or Obesity
RECRUITING360 Analytics
NCT07431086Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the USOverweight or Obesity
ACTIVE NOT_RECRUITING120 Analytics
PHASE2RECRUITING
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or ObesityUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US
Overweight or ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Maximum plasma Concentration (Cmax)
At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
At week 15 and week 24

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Olatorepatide arm 1EXPERIMENTAL -
Olatorepatide arm 2EXPERIMENTAL -
Olatorepatide arm 3EXPERIMENTAL -
Olatorepatide arm 4EXPERIMENTAL -
Olatorepatide arm 5EXPERIMENTAL -
Matching Placebo arm 6ACTIVE_COMPARATOR -
General CohortEXPERIMENTAL -
Subgroup CohortEXPERIMENTAL -

Interventions

NameTypeDescription
OlatorepatideDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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...

Countries:United States
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07685808Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07685808Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 6, 2026NCT07685808NEW_TRIAL: changed
LOWJul 6, 2026NCT07685808NEW_TRIAL: changed
MEDIUMJun 18, 2026NCT07431086Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT07431086Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT07431086Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT07431086Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Olatorepatide

What is Olatorepatide used for?

Olatorepatide is an investigational small molecule being developed for the treatment of overweight or obesity. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in adult participants living with overweight or obesity, including those without diabetes.

Who makes Olatorepatide?

Olatorepatide is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting Phase 2 clinical trials to evaluate the drug's safety and efficacy in adults with overweight or obesity.

What phase is Olatorepatide in?

Olatorepatide is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 2 trials are ongoing, one active but not recruiting and one currently recruiting participants.

What clinical trials is Olatorepatide in?

Olatorepatide is being studied in two Phase 2 clinical trials. The first, NCT07431086, is a study in adult participants with overweight or obesity in the US, with 120 participants enrolled. The second, NCT07685808, is a study in adults with overweight or obesity without diabetes, with 360 participants. Both are randomized, double-blind, and controlled.

How does Olatorepatide work?

Olatorepatide is a peptide-based small molecule, classified under the -tide (peptide) target class. It is being investigated for its potential to treat overweight or obesity, though its specific molecular target has not been disclosed. The drug is administered as a small molecule and is currently in Phase 2 trials.