A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity (ATTAIN-NOW)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Prehypertension; Prediabetic State; Overweight; Obesity, Abdominal

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07794579

J2A-MC-GZVA (Other Identifier)

27823

2026-526175-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 2,001 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,001 participants in 3 patient groups

Orforglipron

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron to Placebo

Experimental group

Description:

Participants will receive orforglipron orally followed by placebo orally

Treatment:

Drug: Placebo

Drug: Orforglipron

Placebo to Orforglipron

Experimental group

Description:

Participants will receive placebo orally followed by orforglipron orally

Treatment:

Drug: Placebo

Drug: Orforglipron