A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05872620

18560 (Other Identifier)

U1111-1289-8799 (Other Identifier)

2022-502837-24-00 (Other Identifier)

J2A-MC-GZGQ (Other Identifier)

Details and patient eligibility

About

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).

• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

• Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

  • either diet/exercise alone or
  • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion criteria

• Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
• Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
• Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
• Have had a history of chronic or acute pancreatitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,500 participants in 4 patient groups, including a placebo group

Orforglipron Dose 1

Experimental group

Description:

Participants will receive orforglipron administered orally.

Treatment:

Drug: Orforglipron

Orforglipron Dose 2

Experimental group

Description:

Participants will receive orforglipron administered orally.

Treatment:

Drug: Orforglipron

Orforglipron Dose 3

Experimental group

Description:

Participants will receive orforglipron administered orally.

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo

Treatment:

Drug: Placebo