A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Plain English Summary

A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight Without Type 2 Diabetes is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Obesity or Overweight. Tests a new drug for weight loss in people with obesity or overweight without Type 2 diabetes. For adults aged 18 and older with a BMI of 30 or higher, or a BMI of 27 or higher with at least one weight-related health issue. Participation involves weekly injections of the study drug or a placebo for up to 72 weeks. Alternative treatments include lifestyle changes, diet, and other weight loss medications. The trial aims to enroll 2000 participants.

Official Summary

The purpose of this study is to assess the efficacy and safety of RO7795068, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible participants must have a BMI of 30 or higher, or 27 or higher with a weight-related health issue. Cannot have Type 1 or 2 diabetes, recent weight loss, or certain medical conditions like heart disease or severe depression. Must be able to self-administer the study drug or have assistance if needed. Cannot have had recent surgery for weight loss or certain digestive issues. This trial is studying Obesity or Overweight, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the percentage of weight loss in participants, which can help patients understand if the drug is effective for them. The specific primary outcome measures are: Percent (%) Change from Baseline in Body Weight at Week 72 (Baseline through Week 72). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a gap in treatment options for those with obesity or overweight without Type 2 diabetes, offering a new approach to weight management. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Obesity or Overweight, where improved treatment options are needed.

Investor Insight

The large market size and competitive landscape suggest a high probability of approval, making this an attractive investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 2000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have a BMI of 30 or higher, or 27 or higher with a weight-related health issue. Participation involves weekly injections of the study drug or a placebo for up to 72 weeks. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 2,000 participants

Interventions

• COMBINATION_PRODUCT: Placebo — Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
• COMBINATION_PRODUCT: RO7795068 — RO7795068 will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Primary Outcomes

• Percent (%) Change from Baseline in Body Weight at Week 72 (Baseline through Week 72)

Secondary Outcomes

• Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72 (Baseline and Week 72)
• Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72 (Baseline and Week 72)
• Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72 (Baseline and Week 72)
• Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72 (Baseline and Week 72)
• Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72 (Baseline and Week 72)

Full Eligibility Criteria

Inclusion Criteria:

* Participants must have at screening:

  1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
  2. BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

Exclusion Criteria:

* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
* Poorly controlled hypertension at screening
* Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
* Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Trial Locations

• Elevate Clinical Research, Gurnee, Illinois, United States
• Clinical Research Associates, Nashville, Tennessee, United States

Frequently Asked Questions

Related Conditions

• Obesity, Type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, depression

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