A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
- Summary
- This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.
- Acronym
- ATTAIN-NOW
- Short title
- A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2030-09-01
- First posted
- 2026-08-31
- Registry last updated
- 2026-10-08
- Primary completion date
- 2029-08-01
- Start date
- 2026-08-26
- Participants
- 2,001
- Participant count basis
- Estimated
- Planned participants
- 2,001
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07794579
- ClinicalTrials.gov ID
- NCT07794579
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Time to Onset of Obesity Related Complications or Class 1 Obesity
Timeframe: Baseline to Week 104
Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold
Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 104
Time to Onset of Waist-to-Height Ratio ≥0.6
Timeframe: Baseline to Week 104
Change from Baseline in Waist Circumference
Timeframe: Baseline, Week 104
Time to Onset of Class 1 Obesity
Timeframe: Baseline to Week 104
Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia
Timeframe: Baseline to Week 104
Time to Onset of Type 2 Diabetes
Timeframe: Baseline to Week 104
Percent Change from Baseline in Total Fat Mass
Timeframe: Baseline, Week 104
Change from Baseline in Systolic Blood Pressure
Timeframe: Baseline, Week 104
Change from Baseline in Glycated Hemoglobin (HbA1c)
Timeframe: Baseline, Week 104
Percent Change from Baseline in Triglycerides
Timeframe: Baseline, Week 104
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score
Timeframe: Baseline, Week 104
Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron
Timeframe: Week 4, 12, 24, 52, and 76
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Have an increased waist-to-height ratio of ≥0.5
- Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)
- Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
- Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Do not have a stable body weight within 90 days before screening
- Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold)
- Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening
- Have a prior or planned surgical treatment or procedure for obesity
- Have hypertension or history of hypertension
- Have dyslipidemia or history of dyslipidemia
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And 155 more, listed on the interactive page.
- Related resource (trials.lilly.com)
- 2026-526175-35-00
- J2A-MC-GZVA