Overweight or ObesityPhase 2NCT07685808
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
A Phase 2 study testing Olatorepatide in people with Overweight or Obesity, run by Regeneron Pharmaceuticals at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 360 participants
- Where
- 21 sitesUnited States
- Study dates
- 28 Jul 2026to 21 Jan 2028
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 21 recruiting
- Recruiting
Charter Research LLC - Chicago
Chicago, Illinois, 60618
- Recruiting
Flourish Research - Chicago
Chicago, Illinois, 60625
- Recruiting
Alliance for Multispecialty Research (AMR) Clinical Miami
Doral, Florida, 33172
- Recruiting
AMR Clinical - Fort Myers
Fort Myers, Florida, 33912
- Recruiting
Tribe Clinical Research
Greenville, South Carolina, 29607
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012
- Recruiting
Flourish Research, Nature Coast Clinical Research
Inverness, Florida, 34452
- Recruiting
Flourish Research, Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
- Recruiting
AMR Clinical - Lexington
Lexington, Kentucky, 40509
- Recruiting
K2 Medical Research Maitland LLC, Main Office
Maitland, Florida, 32751
- Recruiting
AMR Clinical - Mobile
Mobile, Alabama, 36608
- Recruiting
NYC Research Inc
New York, New York, 10016
- Recruiting
AMR Clinical - Chicago Oak Brook
Oak Brook, Illinois, 60523
- Recruiting
Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134
- Recruiting
Rochester Clinical Research
Rochester, New York, 14609
- Recruiting
The IMA Group, IMA Clinical Research St. Petersburg
St. Petersburg, Florida, 33704
- Recruiting
Charter Research LLC - The Villages
The Villages, Florida, 32162
- Recruiting
Diablo Clinical Research - Flourish Research
Walnut Creek, California, 94598
- Recruiting
Chase Medical Research
Waterbury, Connecticut, 06708
- Recruiting
AMR Clinical - Wichita
Wichita, Kansas, 67207
- Recruiting
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, 32789
About this study
Official title: A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity
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
- Conditions
- Overweight or Obesity
- Being tested
- Olatorepatide, Placebo
- Keywords
- Body weight, Glucagon-Like Peptide-1 (GLP-1)/Gastric inhibitory polypeptide (GIP) receptor agonist, Dose-finding, Control appetite
- 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 |
|---|---|---|
| Olatorepatide arm 1 | Experimental | Not described Receives: Drug: Olatorepatide |
| Olatorepatide arm 2 | Experimental | Not described Receives: Drug: Olatorepatide |
| Olatorepatide arm 3 | Experimental | Not described Receives: Drug: Olatorepatide |
| Olatorepatide arm 4 | Experimental | Not described Receives: Drug: Olatorepatide |
| Olatorepatide arm 5 | Experimental | Not described Receives: Drug: Olatorepatide |
| Matching Placebo arm 6 | Active comparator | Not described Receives: 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 60 weeks
Severity of TEAEs
Measured: Up to approximately 60 weeks
Percent change in body weight
Measured: From baseline to week 52
Secondary outcomes (3)
Olatorepatide concentrations
Measured: Up to approximately 60 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Measured: Up to approximately 52 weeks
Magnitude of ADA to olatorepatide
Measured: Up to approximately 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start28 Jul 2026
- Primary completion21 Jan 2028 (estimated)
- Study completion21 Jan 2028 (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
- 360 participants (estimated)
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
- NCT07685808
- Sponsor's protocol ID
- HS-20094-OB-25106
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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