Overweight or ObesityPhase 2NCT07431086
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US
A Phase 2 study testing Olatorepatide in people with Overweight or Obesity, run by Regeneron Pharmaceuticals at 3 sites in United States.
Trial summary
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Olatorepatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Mar 2026to 18 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index ≥27.0 kg/m^2 to <45.0 kg/m^2 at screening
- Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment
Who cannot join
- History of Type 1 or Type 2 diabetes
- 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, prior to randomization or planned during the study period
- History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Flourish Research - San Antonio Medical Trials
San Antonio, Texas, 78229
Diablo Clinical Research - Flourish Research
Walnut Creek, California, 94598
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, 32789
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, Tolerability, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity in the US
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity.
The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes.
The study is looking at:
- What side effects the study drug might cause
- How much the study drug is in the blood at different times
- How well the study drug works
- If the body makes antibodies to the study drug as this may cause the study drug to not work as well
- Conditions
- Overweight or Obesity
- Being tested
- Olatorepatide, Placebo
- Keywords
- Body weight, Waist circumference, Glucagon-Like Peptide-1 (GLP-1) receptor agonist, Control appetite, Glucose-dependent Insulinotropic Polypeptide (GIP)
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlatorepatideDrug
Also called HS-20094
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| General Cohort | Experimental | Not described Receives: Drug: Olatorepatide; Drug: Placebo |
| Subgroup Cohort | Experimental | Not described Receives: Drug: Olatorepatide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 30 weeks
Severity of TEAEs
Measured: Up to approximately 30 weeks
Maximum plasma Concentration (Cmax)
Measured: At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
Measured: At week 15 and week 24
Secondary outcomes (12)
Percent change in body weight
Measured: From baseline to week 25
Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)
Measured: From baseline to weeks 7, 15 and 24
Change in in-clinic SBP
Measured: From baseline to weeks 7, 15 and 24
Lowest concentration in a dosing interval (Ctrough)
Measured: Up to approximately 30 weeks
Time to Cmax (Tmax)
Measured: Up to approximately 30 weeks
Apparent Volume of distribution (Vd/F)
Measured: Up to approximately 30 weeks
Apparent clearance (CL/F)
Measured: Up to approximately 30 weeks
Apparent terminal half-life (t½)
Measured: Up to approximately 30 weeks
Olatorepatide concentrations
Measured: Up to approximately 30 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Measured: Up to approximately 30 weeks
Magnitude of ADA to olatorepatide
Measured: Up to approximately 30 weeks
Corrected QT interval using the Fridericia formula (QTcF)
Measured: Pre-dose to up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start16 Mar 2026
- Primary completion13 Nov 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431086
- Sponsor's protocol ID
- HS-20094-OB-2569
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, Tolerability, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity in the US
- ClinicalTrials.gov ID
- NCT07431086
- Acronym / sponsor ID
- HS-20094-OB-2569
- Conditions
- Overweight or Obesity
- Keywords
- Body weight, Waist circumference, Glucagon-Like Peptide-1 (GLP-1) receptor agonist, Control appetite, Glucose-dependent Insulinotropic Polypeptide (GIP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity.
The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes.
The study is looking at:
- What side effects the study drug might cause
- How much the study drug is in the blood at different times
- How well the study drug works
- If the body makes antibodies to the study drug as this may cause the study drug to not work as well
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Cohort | Experimental | Drug: Olatorepatide, Drug: Placebo |
| Subgroup Cohort | Experimental | Drug: Olatorepatide, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index ≥27.0 kg/m^2 to <45.0 kg/m^2 at screening
- Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment
Key exclusion criteria (5 listed)
- History of Type 1 or Type 2 diabetes
- 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, prior to randomization or planned during the study period
- History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlatorepatideAlso: HS-20094Administered per the protocol | Drug | General Cohort, Subgroup Cohort |
| PlaceboAdministered per the protocol | Drug | General Cohort, Subgroup Cohort |
Primary outcome
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 30 weeks
Severity of TEAEs
Time frame: Up to approximately 30 weeks
Maximum plasma Concentration (Cmax)
Time frame: At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
Time frame: At week 15 and week 24
12 secondary outcomes
Percent change in body weight
Time frame: From baseline to week 25
Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)
Time frame: From baseline to weeks 7, 15 and 24
Change in in-clinic SBP
Time frame: From baseline to weeks 7, 15 and 24
Lowest concentration in a dosing interval (Ctrough)
Time frame: Up to approximately 30 weeks
Time to Cmax (Tmax)
Time frame: Up to approximately 30 weeks
Apparent Volume of distribution (Vd/F)
Time frame: Up to approximately 30 weeks
Apparent clearance (CL/F)
Time frame: Up to approximately 30 weeks
Apparent terminal half-life (t½)
Time frame: Up to approximately 30 weeks
Olatorepatide concentrations
Time frame: Up to approximately 30 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Time frame: Up to approximately 30 weeks
Magnitude of ADA to olatorepatide
Time frame: Up to approximately 30 weeks
Corrected QT interval using the Fridericia formula (QTcF)
Time frame: Pre-dose to up to 48 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olatorepatide in people with Overweight or Obesity, run by Regeneron Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to approximately 30 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.