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 and Type 2 Diabetes

Plain English Summary

A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Obesity or Overweight, Type 2 Diabetes Mellitus. Tests a new drug for weight loss in people with obesity or overweight and Type 2 diabetes. For adults with obesity or overweight and Type 2 diabetes who have tried diet and exercise. Participation involves weekly injections of the study drug or a placebo. Alternatives include lifestyle changes, diet, and other diabetes medications. The trial aims to enroll 1600 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if you have obesity or overweight and Type 2 diabetes, and have tried diet and exercise. Not eligible if you have Type 1 diabetes, severe hypoglycemia, or certain heart conditions. Must be at least 18 years old and have a BMI of 27 or higher. Must not have had weight loss surgery or certain endocrine disorders. This trial is studying Obesity or Overweight, Type 2 Diabetes Mellitus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study measures how much weight participants lose and how well their blood sugar levels improve. 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 people with obesity and Type 2 diabetes who need more effective 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, Type 2 Diabetes Mellitus, where improved treatment options are needed.

Investor Insight

This trial could lead to new treatment options for millions of people with obesity and Type 2 diabetes, potentially improving their quality of life. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1600 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have any history of severe hypoglycemia or heart conditions. You will receive weekly injections of the study drug or a placebo. This trial is currently recruiting participants. The trial is being conducted at 3 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: 1,600 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)
• Change from Baseline in Body Weight (kg) at Week 72 (Baseline through Week 72)
• Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 (Baseline through Week 72)

Full Eligibility Criteria

Inclusion Criteria:

* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
* Body mass index (BMI) ≥27.0 kg/m\^2
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
* 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)
* Poorly controlled hypertension at screening
* Have 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
* 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

• Ark Clinical Research, Long Beach, California, United States
• Progressive Medical Research, Port Orange, Florida, United States
• Remington Davis Inc, Columbus, Ohio, United States

Frequently Asked Questions

Related Conditions

• Conditions: Obesity, Overweight, Type 2 Diabetes
• Therapeutic Areas: Endocrinology, Metabolism, Diabetes

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