Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body Mass Index (BMI) ≥30.0 kg/m² to <45.0 kg/m² at screening OR

BMI ≥27.0 kg/m² 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olatorepatide

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

360 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Olatorepatide arm 1Experimental treatment 1 intervention
Group B: Olatorepatide arm 2Experimental treatment 1 intervention
Group C: Olatorepatide arm 3Experimental treatment 1 intervention
Group D: Olatorepatide arm 4Experimental treatment 1 intervention
Group E: Olatorepatide arm 5Experimental treatment 1 intervention
Group F: Matching Placebo arm 6Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to approximately 60 weeks
2

Severity of TEAEs

Time frame
Up to approximately 60 weeks
3

Percent change in body weight

Time frame
From baseline to week 52

Secondary outcomes

1

Olatorepatide concentrations

Time frame
Up to approximately 60 weeks
2

Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

Time frame
Up to approximately 52 weeks
3

Magnitude of ADA to olatorepatide

Time frame
Up to approximately 52 weeks

Other outcomes

Sponsors and contacts

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