Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olatorepatide, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight or Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Drug Olatorepatide
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 60 weeks]
- Severity of TEAEs [Time frame: Up to approximately 60 weeks]
- Percent change in body weight [Time frame: From baseline to week 52]
Secondary outcome measures (3)
- Olatorepatide concentrations [Time frame: Up to approximately 60 weeks]
- Occurrence of Anti-Drug Antibody (ADA) to olatorepatide [Time frame: Up to approximately 52 weeks]
- Magnitude of ADA to olatorepatide [Time frame: Up to approximately 52 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07685808 · HS-20094-OB-25106