Clinical trial

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

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07685808

Recruiting nowPhase 2Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionOverweight or Obesity

Full registry 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 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

Treatments and study arms

Olatorepatide

Drug

Administered per the protocol

Placebo

Drug

Administered per the protocol

Primary outcomes

Occurrence of Treatment-Emergent Adverse Events (TEAEs)Up to approximately 60 weeks

Severity of TEAEsUp to approximately 60 weeks

Percent change in body weightFrom baseline to week 52

Study locations

5 locations were listed when this page was built. The first 40 are shown.

AMR Clinical - Lexington🇺🇸 Lexington, Kentucky, United States

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K2 Medical Research Maitland LLC, Main Office🇺🇸 Maitland, Florida, United States

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Charter Research LLC - The Villages🇺🇸 The Villages, Florida, United States

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Diablo Clinical Research - Flourish Research🇺🇸 Walnut Creek, California, United States

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Clinical Site Partners, LLC DBA Flourish Research🇺🇸 Winter Park, Florida, United States

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