No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults who are overweight or obese but do not have diabetes. Participants will take an experimental drug called olatorepatide to see how safe it is and how it works in the body.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetesPancreatitisGallbladder issues
You may be able to join if
I have a BMI of 30.0 to less than 45.0
I have a BMI of 27.0 or higher and have weight-related health issues
You may not be able to join if
I have been diagnosed with Type 1 or Type 2 diabetes
I have gained or lost more than 5 kg in the last 3 months
I have had bariatric surgery in the past
I have a history of pancreatitis or gallbladder issues
I or my family have a history of certain thyroid or endocrine cancers
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 lookin…
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 Locations
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Eligibility 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…
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
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